The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Monark 869 Ergometer.
| Device ID | K855102 |
| 510k Number | K855102 |
| Device Name: | MONARK 869 ERGOMETER |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-05-09 |