The following data is part of a premarket notification filed by Portable Travtion Device Co. with the FDA for Computerized Tomography-hyperbaric Oxyg.
| Device ID | K831888 |
| 510k Number | K831888 |
| Device Name: | COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | PORTABLE TRAVTION DEVICE CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-13 |
| Decision Date | 1983-07-12 |