The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Modification To Zap Guard Defibrillator Test Probe.
| Device ID | K030547 |
| 510k Number | K030547 |
| Device Name: | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE |
| Classification | Tester, Defibrillator |
| Applicant | GUARDIAN ANGEL PRODUCTS, INC. 2771 PHILMONT AVE. Huntingdon Valley, PA 19006 |
| Contact | Ernest H Pescatore |
| Correspondent | Ernest H Pescatore GUARDIAN ANGEL PRODUCTS, INC. 2771 PHILMONT AVE. Huntingdon Valley, PA 19006 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-07-11 |
| Summary: | summary |