The following data is part of a premarket notification filed by First Medical Devices Corp. with the FDA for First Medic Mode 610.
| Device ID | K883584 |
| 510k Number | K883584 |
| Device Name: | FIRST MEDIC MODE 610 |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-10-06 |