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

Device, Temperature Measurement, Direct Contact, Powered

21 CFR 882.1570 / Neurology
FDA source (opens on fda.gov)

HCS is the FDA product code for Device, Temperature Measurement, Direct Contact, Powered, a class II device type, regulated under 21 CFR 882.1570. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HCS
Device name
Device, Temperature Measurement, Direct Contact, Powered
Regulation
21 CFR 882.1570
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code HCS

By decision year
8 clearances under product code HCS with a decision year between 1982 and 1998, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HCS by decision year
YearClearances
19822
19831
19841
19891
19951
19982

Applicants with the most clearances

Product code HCS
Applicants holding the most 510(k) clearances under product code HCS
ApplicantClearances
Gabriel Ent.2
Artronics1
K.J. Electronics1
Medical Equipment Designs, Inc.1
Medtech Instruments1
Pos Technologies, Inc.1
Titronics Research & Development1

Companies listing this code with FDA

Companies whose registered establishments list this code

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