The following data is part of a premarket notification filed by Transamerican Medical Imaging with the FDA for Spectre Wireless Encrypted Footswitch And Hand Switch System.
| Device ID | K092713 |
| 510k Number | K092713 |
| Device Name: | SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | TRANSAMERICAN MEDICAL IMAGING 965 WEST 325 NORTH Lindon, UT 84042 |
| Contact | Robert H Woodward |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2010-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B308SPECT0 | K092713 | 000 |