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FDA 510(k)

DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)

K-Number: K883324 · 1989-02-27

ApplicantSiemens Gammasonics, Inc.
Decision Date1989-02-27
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K883324. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)?

DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K883324.

When did DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) receive FDA 510(k) clearance?

DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) received FDA 510(k) clearance on 1989-02-27, under 510(k) number K883324.

Who is the listed applicant for DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)?

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

What is the FDA product code for DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)?

The FDA product code for DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) is LMC.

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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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