The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Erg 550 Ergometer Bicycle.
| Device ID | K854491 |
| 510k Number | K854491 |
| Device Name: | ERG 550 ERGOMETER BICYCLE |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Contact | Andrew Schaeffer |
| Correspondent | Andrew Schaeffer ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-06-16 |