The following data is part of a premarket notification filed by Treymed, Inc. with the FDA for Metaphor Metabolic Monitor.
| Device ID | K093080 |
| 510k Number | K093080 |
| Device Name: | METAPHOR METABOLIC MONITOR |
| Classification | Computer, Oxygen-uptake |
| Applicant | TREYMED, INC. N56 W24790 N. CORPORATE CIRCLE UNIT C Sussex, WI 53089 |
| Contact | Robert H Ricciardelli |
| Correspondent | Robert H Ricciardelli TREYMED, INC. N56 W24790 N. CORPORATE CIRCLE UNIT C Sussex, WI 53089 |
| Product Code | BZL |
| Subsequent Product Code | BZC |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B23133151 | K093080 | 000 |
| B23133141 | K093080 | 000 |
| B23133131 | K093080 | 000 |
| B23133121 | K093080 | 000 |