The following data is part of a premarket notification filed by Pt&e with the FDA for Electronic Apgar Timer.
Device ID | K811424 |
510k Number | K811424 |
Device Name: | ELECTRONIC APGAR TIMER |
Classification | Timer, Apgar |
Applicant | PT&E 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHB |
CFR Regulation Number | 880.2930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-22 |
Decision Date | 1981-07-09 |