The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Aid, Cardiopulmonary Resuscitation.
Device ID | K930429 |
510k Number | K930429 |
Device Name: | AID, CARDIOPULMONARY RESUSCITATION |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
Contact | Thomas J Gilloway |
Correspondent | Thomas J Gilloway VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1993-03-11 |