The following data is part of a premarket notification filed by First Medical Devices Corp. with the FDA for Heartstart 2000 Defibrillator Tester, Ecg.
| Device ID | K880780 |
| 510k Number | K880780 |
| Device Name: | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG |
| Classification | Tester, Defibrillator |
| Applicant | FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150 (PER DO, FIRM OOB) Bellevue, WA 98005 |
| Contact | Bruce Haggar |
| Correspondent | Bruce Haggar FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150 (PER DO, FIRM OOB) Bellevue, WA 98005 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-05-12 |