MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT— 510(k) K945845

Name: FDA 510(k) clearance K945845
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent

Micos Medical Systems

FDA 510(k) clearance K945845 for MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT, Substantially Equivalent on 1995-05-03. Applicant: Micos Medical Systems. Device class: 2.

Clearance details

Applicant: Micos Medical Systems
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1994-11-30
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hickory Corners, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FNM

view all

K973169 — PRESSURE GUARD SITE SELECT (A)1998-02-20
K972022 — ZAK-20001998-01-22
K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

More clearances from Micos Medical Systems

view all

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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 →

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