The following data is part of a premarket notification filed by General Devices with the FDA for Prep-check.
Device ID | K830876 |
510k Number | K830876 |
Device Name: | PREP-CHECK |
Classification | Tester, Electrode, Surface, Electrocardiographic |
Applicant | GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
Contact | Michael Smith |
Correspondent | Michael Smith GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
Product Code | KRC |
CFR Regulation Number | 870.2370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-18 |
Decision Date | 1983-05-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00862186000317 | K830876 | 000 |
00862186000300 | K830876 | 000 |