The following data is part of a premarket notification filed by Keller Medical Specialties Products, Inc. with the FDA for Dispos Access External Cardiac Pacemaker.
| Device ID | K903437 |
| 510k Number | K903437 |
| Device Name: | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Contact | Jay Keller |
| Correspondent | Jay Keller KELLER MEDICAL SPECIALTIES PRODUCTS, INC. 42609 CRAWFORD RD. Antioch, IL 60002 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-11-16 |