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

Chamber, Reverse Isolation, Patient Care

21 CFR 880.5450 / General Hospital
FDA source (opens on fda.gov)

FRR is the FDA product code for Chamber, Reverse Isolation, Patient Care, a class II device type, regulated under 21 CFR 880.5450. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FRR
Device name
Chamber, Reverse Isolation, Patient Care
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code FRR

By decision year
1 clearance under product code FRR with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FRR by decision year
YearClearances
19941

Applicants with the most clearances

Product code FRR
Applicants holding the most 510(k) clearances under product code FRR
ApplicantClearances
Viva-Tek Assoc., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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