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FDA 510(k)

SMR H-CHAIR

K-Number: K800526 · 1980-03-18

ApplicantSurgical Mechanical Research, Inc.
Decision Date1980-03-18
Product CodeETF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SMR H-CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Mechanical Research, Inc.. It received FDA 510(k) clearance on 1980-03-18 under 510(k) number K800526. The device is classified under product code ETF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR H-CHAIR?

SMR H-CHAIR is a medical device that received FDA 510(k) clearance on 1980-03-18. The listed applicant is Surgical Mechanical Research, Inc.. The 510(k) number is K800526.

When did SMR H-CHAIR receive FDA 510(k) clearance?

SMR H-CHAIR received FDA 510(k) clearance on 1980-03-18, under 510(k) number K800526.

Who is the listed applicant for SMR H-CHAIR?

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

What is the FDA product code for SMR H-CHAIR?

The FDA product code for SMR H-CHAIR is ETF.

Related Clinical Trials

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.

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Other records listing Surgical Mechanical Research, 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.

K803195SYSTEM 1 INSTRUMENT STANDK800382CLEAR-VIEW MIRROR WARMERK781801MAXI-CHAIR

Related Devices (Code: ETF)

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.

K953457JEDMED SPECTRUM ENT CABINETJedmed Instrument Co.K945395PREMIER MIRROR WARMERPremier Dental Products Co.K932470LANGGASSE 90Happersberger Otopront GmbHK911901MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCEStortzK910781#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCESMidmark Corp.K910243MOBILE TREATMENT CARTJedmed Instrument Co.

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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