SPACELABS ALPHA PC PATIENT COMPUTER— 510(k) K842616

Name: FDA 510(k) clearance K842616
Creator: U.S. Food and Drug Administration
Published: 1984-10-18

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K842616 for SPACELABS ALPHA PC PATIENT COMPUTER, Substantially Equivalent on 1984-10-18. Applicant: Spacelabs, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1984-07-05
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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K231276 — SmartCardia 7L Platform2023-08-30

More clearances from Spacelabs, Inc.

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K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER1996-05-31
K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM1995-07-14
K950779 — HEART RATE VARIABILITY SOFTWARE OPTION1995-04-25
K941165 — COMET CAPNOGRAPH MODULE1994-10-06
K923788 — SPACE LABS MODEL 905601993-12-06

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K842616

K-number listed on FDA's recall record

Z-2382-2012 — Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.Class II·Terminated·Spacelabs Healthcare, Llc·20120827

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K842616.

Data sourced from openFDA. This site is unofficial and independent of the FDA.