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

Hood, Oxygen, Infant

21 CFR 868.5700 / Anesthesiology
FDA source (opens on fda.gov)

FOG is the FDA product code for Hood, Oxygen, Infant, a class I device type, regulated under 21 CFR 868.5700. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FOG
Device name
Hood, Oxygen, Infant
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code FOG

By decision year
9 clearances under product code FOG with a decision year between 1977 and 1997, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FOG by decision year
YearClearances
19771
19781
19793
19831
19962
19971

Applicants with the most clearances

Product code FOG
Applicants holding the most 510(k) clearances under product code FOG
ApplicantClearances
Advantage Medical Services, Inc.1
American Cystocope Makers, Inc.1
Ann Arbor Plastics, Inc.1
Jayco Pharmaceuticals1
OLYMPUS Corporation of the Americas1
Plastics Supplies & Products1
Promedic, Inc.1
Shiley, Inc.1
Utah Medical Products, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order