The following data is part of a premarket notification filed by Keller Medical Specialties Products, Inc. with the FDA for Keller Cardiac Monitor Medil Kms870.
| Device ID | K914576 |
| 510k Number | K914576 |
| Device Name: | KELLER CARDIAC MONITOR MEDIL KMS870 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-15 |
| Decision Date | 1991-12-30 |