510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IYYClass I

Synchronizer, Electrocardiograph, Nuclear

21 CFR 892.1410 / Radiology
FDA source (opens on fda.gov)

IYY is the FDA product code for Synchronizer, Electrocardiograph, Nuclear, a class I device type, regulated under 21 CFR 892.1410. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYY
Device name
Synchronizer, Electrocardiograph, Nuclear
Regulation
21 CFR 892.1410
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code IYY

By decision year
3 clearances under product code IYY with a decision year between 1978 and 1986, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IYY by decision year
YearClearances
19781
19791
19861

Applicants with the most clearances

Product code IYY
Applicants holding the most 510(k) clearances under product code IYY
ApplicantClearances
Amr Co.1
Bios, Inc.1
Mirion Technologies (Capintec), Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code