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 |