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

Mattress, Water, Temperature Regulated

21 CFR 880.5560 / General Hospital
FDA source (opens on fda.gov)

FOH is the FDA product code for Mattress, Water, Temperature Regulated, a class I device type, regulated under 21 CFR 880.5560. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FOH
Device name
Mattress, Water, Temperature Regulated
Regulation
21 CFR 880.5560
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code FOH

By decision year
6 clearances under product code FOH with a decision year between 1981 and 1995, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FOH by decision year
YearClearances
19814
19871
19951

Applicants with the most clearances

Product code FOH
Applicants holding the most 510(k) clearances under product code FOH
ApplicantClearances
Pharmaquest Corp.4
Intl. Management Services, Inc.1
Olympic Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code