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FDA 510(k)

HYPERBARIC OXYGEN GURNEY-

K-Number: K841368 · 1984-05-16

ApplicantOrthopedic Systems, Inc.
Decision Date1984-05-16
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYPERBARIC OXYGEN GURNEY- is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K841368. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERBARIC OXYGEN GURNEY-?

HYPERBARIC OXYGEN GURNEY- is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K841368.

When did HYPERBARIC OXYGEN GURNEY- receive FDA 510(k) clearance?

HYPERBARIC OXYGEN GURNEY- received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841368.

Who is the listed applicant for HYPERBARIC OXYGEN GURNEY-?

The FDA 510(k) record lists Orthopedic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERBARIC OXYGEN GURNEY-?

The FDA product code for HYPERBARIC OXYGEN GURNEY- is HST.

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Other records listing Orthopedic Systems, Inc. as applicant

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Related Devices (Code: HST)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.K110858LO-BAK TRAXRoland F Berthiaume, DCK984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.K872121K AND D HOME TRACTJoseph A. Kott, M.D.K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.K870125EXTREMITY ELEVATOROrthopedic Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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