The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Zap-guard.
Device ID | K896985 |
510k Number | K896985 |
Device Name: | ZAP-GUARD |
Classification | Tester, Defibrillator |
Applicant | GUARDIAN ANGEL PRODUCTS, INC. SUITE 202 2617 HUNTINGDON PIKE Huntingdon Valley, PA 19006 |
Contact | Michael N Buss |
Correspondent | Michael N Buss GUARDIAN ANGEL PRODUCTS, INC. SUITE 202 2617 HUNTINGDON PIKE Huntingdon Valley, PA 19006 |
Product Code | DRL |
CFR Regulation Number | 870.5325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-13 |
Decision Date | 1990-07-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZAP-GUARD 74275626 1756649 Dead/Cancelled |
Guardian Angel Health Care Products, Inc. 1992-05-15 |