The following data is part of a premarket notification filed by Medical Instruments Technology, Inc. with the FDA for Tourniquet Cuff; Pneumatic Tourniquet.
| Device ID | K012632 |
| 510k Number | K012632 |
| Device Name: | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET |
| Classification | Tourniquet, Pneumatic |
| Applicant | MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| Contact | Jack Speer |
| Correspondent | Jack Speer MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-10-26 |
| Summary: | summary |