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FDA 510(k)

SAPHIRE PLUS SURGICAL MIRROR

K-Number: K934911 · 1994-06-21

ApplicantSan Diego Swiss Machining, Inc.
Decision Date1994-06-21
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SAPHIRE PLUS SURGICAL MIRROR is the device name listed in this FDA 510(k) record. The listed applicant is San Diego Swiss Machining, Inc.. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K934911. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPHIRE PLUS SURGICAL MIRROR?

SAPHIRE PLUS SURGICAL MIRROR is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is San Diego Swiss Machining, Inc.. The 510(k) number is K934911.

When did SAPHIRE PLUS SURGICAL MIRROR receive FDA 510(k) clearance?

SAPHIRE PLUS SURGICAL MIRROR received FDA 510(k) clearance on 1994-06-21, under 510(k) number K934911.

Who is the listed applicant for SAPHIRE PLUS SURGICAL MIRROR?

The FDA 510(k) record lists San Diego Swiss Machining, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPHIRE PLUS SURGICAL MIRROR?

The FDA product code for SAPHIRE PLUS SURGICAL MIRROR is EQH.

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 San Diego Swiss Machining, 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.

K960889SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS

Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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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