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 |