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FDA 510(k)

LEGEND

K-Number: K952441 · 1995-06-19

ApplicantHealth Care Mfg., Inc.
Decision Date1995-06-19
Product CodeINQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LEGEND is the device name listed in this FDA 510(k) record. The listed applicant is Health Care Mfg., Inc.. It received FDA 510(k) clearance on 1995-06-19 under 510(k) number K952441. The device is classified under product code INQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGEND?

LEGEND is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Health Care Mfg., Inc.. The 510(k) number is K952441.

When did LEGEND receive FDA 510(k) clearance?

LEGEND received FDA 510(k) clearance on 1995-06-19, under 510(k) number K952441.

Who is the listed applicant for LEGEND?

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

What is the FDA product code for LEGEND?

The FDA product code for LEGEND is INQ.

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Other records listing Health Care Mfg., Inc. as applicant

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.

K022737HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHICK022667HCMI X-RAYK951323VH-2000K951382HLT 406K944699ATT-300K944329BACK SPECIALIST

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Related Devices (Code: INQ)

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.

K960334CARDON PHYSICAL THERAPY TABLE MODEL R27116Cardon Rehabilitation Products, Inc.K960336CARDON PHYSICAL THERAPY TABLE MODEL R27645Cardon Rehabilitation Products, Inc.K960332CARDON PHYSICAL THERAPY TABLE MODEL R28598Cardon Rehabilitation Products, Inc.K960196TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777Tri W-G, Inc.K953621EVT-3300U.S. Table, Inc.K953622PTT 6200 ELEVATION THERAPY TABLEU.S. Table, 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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