NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20— 510(k) K863494

Name: FDA 510(k) clearance K863494
Creator: U.S. Food and Drug Administration
Published: 1986-12-22

Substantially Equivalent

Advantage Medical Systems, Inc.

FDA 510(k) clearance K863494 for NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20, Substantially Equivalent on 1986-12-22. Applicant: Advantage Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Advantage Medical Systems, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1986-09-09
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamden, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Advantage Medical Systems, Inc.

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K873957 — NON-CORING HUBER TYPE NEEDLES1987-10-23
K873290 — LACERATION AND INSTRUMENT TRAYS1987-09-24
K861556 — MODIFIED FETAL MONITOR MODEL FM-21986-07-07
K861279 — FLUORO PLUS1986-06-16
K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER1986-05-30

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.