The following data is part of a premarket notification filed by Micromedical Industries, Ltd. with the FDA for Modified Biolog.
| Device ID | K915624 |
| 510k Number | K915624 |
| Device Name: | MODIFIED BIOLOG |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Contact | Edward Hawfield |
| Correspondent | Edward Hawfield MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-03-27 |