The following data is part of a premarket notification filed by Korr Medical Technologies, Inc. with the FDA for Reevue Indirect Calorimeter, Model#8100.
| Device ID | K021490 |
| 510k Number | K021490 |
| Device Name: | REEVUE INDIRECT CALORIMETER, MODEL#8100 |
| Classification | Computer, Oxygen-uptake |
| Applicant | KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUTH SUITE 100 Salt Lake City, UT 84109 |
| Contact | Scott A Kofoed |
| Correspondent | Scott A Kofoed KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUTH SUITE 100 Salt Lake City, UT 84109 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-09 |
| Decision Date | 2003-01-02 |
| Summary: | summary |