The following data is part of a premarket notification filed by Gene R. Baldwin with the FDA for Mask Artificial Respiration.
Device ID | K760941 |
510k Number | K760941 |
Device Name: | MASK ARTIFICIAL RESPIRATION |
Classification | Mask, Oxygen |
Applicant | GENE R. BALDWIN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYG |
CFR Regulation Number | 868.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-01 |
Decision Date | 1977-01-12 |