The following data is part of a premarket notification filed by First Medical Devices Corp. with the FDA for Heartstart 2000, Manual Medical Control Module.
| Device ID | K871135 |
| 510k Number | K871135 |
| Device Name: | HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150 (PER DO, FIRM OOB) Bellevue, WA 98005 |
| Contact | Bruce G Hagger |
| Correspondent | Bruce G Hagger FIRST MEDICAL DEVICES CORP. 2445 140TH AVE NE STE 150 (PER DO, FIRM OOB) Bellevue, WA 98005 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-20 |
| Decision Date | 1987-05-12 |