510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FIWClass II

Alarm, Pillow Pressure

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FIW is the FDA product code for Alarm, Pillow Pressure, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FIW
Device name
Alarm, Pillow Pressure
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code FIW

By decision year
1 clearance under product code FIW with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FIW by decision year
YearClearances
19781

Applicants with the most clearances

Product code FIW
Applicants holding the most 510(k) clearances under product code FIW
ApplicantClearances
Cordis US Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FIW.