The following data is part of a premarket notification filed by Noninvasive Medical Technology Corp. with the FDA for Crit-scan.
| Device ID | K910077 |
| 510k Number | K910077 |
| Device Name: | CRIT-SCAN |
| Classification | Oximeter |
| Applicant | NONINVASIVE MEDICAL TECHNOLOGY CORP. 333 SECOND STREET, SUITE 8 Ogden, UT 84404 |
| Contact | Robert R Steuer |
| Correspondent | Robert R Steuer NONINVASIVE MEDICAL TECHNOLOGY CORP. 333 SECOND STREET, SUITE 8 Ogden, UT 84404 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1992-06-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRIT-SCAN 75816638 not registered Dead/Abandoned |
Non-Invasive Medical Technologies Corporation 1999-10-07 |
![]() CRIT-SCAN 74117528 not registered Dead/Abandoned |
Non-Invasive Medical Technology Corporation 1990-11-23 |