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FDA 510(k)

OPHTHALMIC A-SCAN A-2000 SONOME

K-Number: K843696 · 1985-02-26

ApplicantSonomed Technology, Inc.
Decision Date1985-02-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC A-SCAN A-2000 SONOME is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed Technology, Inc.. It received FDA 510(k) clearance on 1985-02-26 under 510(k) number K843696. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC A-SCAN A-2000 SONOME?

OPHTHALMIC A-SCAN A-2000 SONOME is a medical device that received FDA 510(k) clearance on 1985-02-26. The listed applicant is Sonomed Technology, Inc.. The 510(k) number is K843696.

When did OPHTHALMIC A-SCAN A-2000 SONOME receive FDA 510(k) clearance?

OPHTHALMIC A-SCAN A-2000 SONOME received FDA 510(k) clearance on 1985-02-26, under 510(k) number K843696.

Who is the listed applicant for OPHTHALMIC A-SCAN A-2000 SONOME?

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

What is the FDA product code for OPHTHALMIC A-SCAN A-2000 SONOME?

The FDA product code for OPHTHALMIC A-SCAN A-2000 SONOME is IYO.

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Other records listing Sonomed Technology, 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.

K931909CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GELK931908SONOQUICK ULTRASOUND GELK883917NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANTK844031SONOMED TECH OPHTHALMIC B-SCAN B-3000

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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