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FDA 510(k)

SUPINE STRESS SYSTEM

K-Number: K810238 · 1981-02-13

ApplicantO'Neill
Decision Date1981-02-13
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUPINE STRESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is O'Neill. It received FDA 510(k) clearance on 1981-02-13 under 510(k) number K810238. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPINE STRESS SYSTEM?

SUPINE STRESS SYSTEM is a medical device that received FDA 510(k) clearance on 1981-02-13. The listed applicant is O'Neill. The 510(k) number is K810238.

When did SUPINE STRESS SYSTEM receive FDA 510(k) clearance?

SUPINE STRESS SYSTEM received FDA 510(k) clearance on 1981-02-13, under 510(k) number K810238.

Who is the listed applicant for SUPINE STRESS SYSTEM?

The FDA 510(k) record lists O'Neill as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPINE STRESS SYSTEM?

The FDA product code for SUPINE STRESS SYSTEM is BXB.

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.

Official Source

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

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