PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM— 510(k) K872228

Name: FDA 510(k) clearance K872228
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K872228 for PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM, Substantially Equivalent on 1987-09-04. Applicant: American Pharmaseal Div. Ahsc. Device class: 2.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1987-06-09
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Pharmaseal Div. Ahsc

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K874022 — PHARMASEAL WOUND IRRIGATION DEVICE1987-12-30
K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER1987-12-03
K874517 — PHARMASEAL RUBBER URETHRAL CATHETER1987-12-03
K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER1987-08-11

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.