The following data is part of a premarket notification filed by Korr Medical Technologies, Inc. with the FDA for Accutrax, Model Epf840.
| Device ID | K982995 |
| 510k Number | K982995 |
| Device Name: | ACCUTRAX, MODEL EPF840 |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUIH #3B Salt Lake City, UT 84109 -2106 |
| Contact | Scott Kofoed |
| Correspondent | Scott Kofoed KORR MEDICAL TECHNOLOGIES, INC. 3090 EAST 3300 SOUIH #3B Salt Lake City, UT 84109 -2106 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-27 |
| Decision Date | 1998-12-04 |
| Summary: | summary |