The following data is part of a premarket notification filed by First Medical Devices Corp. with the FDA for First Medic Model 610p.
| Device ID | K895185 |
| 510k Number | K895185 |
| Device Name: | FIRST MEDIC MODEL 610P |
| 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 Haggar |
| Correspondent | Bruce G Haggar 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 | 1989-08-11 |
| Decision Date | 1989-10-27 |