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

Device, Medical Examination, Ac Powered

21 CFR 880.6320 / General Hospital
FDA source (opens on fda.gov)

KZF is the FDA product code for Device, Medical Examination, Ac Powered, a class I device type, regulated under 21 CFR 880.6320. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
KZF
Device name
Device, Medical Examination, Ac Powered
Regulation
21 CFR 880.6320
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
37
Ingested recalls
5

Clearances, product code KZF

By decision year
37 clearances under product code KZF with a decision year between 1978 and 1996, 1993 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code KZF by decision year
YearClearances
19781
19802
19811
19841
19852
19861
19893
19902
19923
199312
19947
19951
19961

Applicants with the most clearances

Product code KZF
Applicants holding the most 510(k) clearances under product code KZF
ApplicantClearances
Medical Illumination, Inc.8
Burton Medical Products Corp.7
Welch Allyn Inc6
Meddev International Corp.2
Abco Dealers, Inc.1
Air-Shields, Inc.1
Berchtold Holding GmbH1
Good-Lite Co.1
JEDMED Instrument Company1
Lada Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order