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510(k) K831888

COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG by Portable Travtion Device Co. — Product Code HST

K831888 is an FDA 510(k) premarket notification submitted by Portable Travtion Device Co. for the device "COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
June 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

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  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)
  • K870125 — EXTREMITY ELEVATOR (February 4, 1987)
  • K870102 — TUPPER TROLLEY (February 3, 1987)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)

FDA data resources