The following data is part of a premarket notification filed by Applied Convergent Technologies, Inc. with the FDA for Resus-aid.
Device ID | K881065 |
510k Number | K881065 |
Device Name: | RESUS-AID |
Classification | Airway, Oropharyngeal, Anesthesiology |
Applicant | APPLIED CONVERGENT TECHNOLOGIES, INC. 15139 DON JULIAN RD. City Of Industry, CA 91747 |
Contact | Wing G Lew |
Correspondent | Wing G Lew APPLIED CONVERGENT TECHNOLOGIES, INC. 15139 DON JULIAN RD. City Of Industry, CA 91747 |
Product Code | CAE |
CFR Regulation Number | 868.5110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-14 |
Decision Date | 1988-07-14 |