The following data is part of a premarket notification filed by First Medical Devices Corp. with the FDA for Model 610 Modified.
| Device ID | K903657 |
| 510k Number | K903657 |
| Device Name: | MODEL 610 MODIFIED |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | FIRST MEDICAL DEVICES CORP. 11810 115TH AVE. NE Kirkland, WA 98034 |
| Contact | Raymond W Gifford |
| Correspondent | Raymond W Gifford FIRST MEDICAL DEVICES CORP. 11810 115TH AVE. NE Kirkland, WA 98034 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-09 |
| Decision Date | 1990-09-04 |