The following data is part of a premarket notification filed by Micromedical Industries, Ltd. with the FDA for Bly-501 Adaptor.
| Device ID | K012540 |
| 510k Number | K012540 |
| Device Name: | BLY-501 ADAPTOR |
| Classification | Electrocardiograph |
| Applicant | MICROMEDICAL INDUSTRIES, LTD. 11 TECHNOLOGY DR. Labrador Queensland, AU 4215 |
| Contact | Stephen Cresswell |
| Correspondent | Stephen Cresswell MICROMEDICAL INDUSTRIES, LTD. 11 TECHNOLOGY DR. Labrador Queensland, AU 4215 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2001-09-26 |
| Summary: | summary |