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FDA 510(k)

LPM-1 (LASER POWER METER)

K-Number: K871619 · 1987-07-28

ApplicantBio-Tek Instruments, Inc.
Decision Date1987-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LPM-1 (LASER POWER METER) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1987-07-28 under 510(k) number K871619. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LPM-1 (LASER POWER METER)?

LPM-1 (LASER POWER METER) is a medical device that received FDA 510(k) clearance on 1987-07-28. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K871619.

When did LPM-1 (LASER POWER METER) receive FDA 510(k) clearance?

LPM-1 (LASER POWER METER) received FDA 510(k) clearance on 1987-07-28, under 510(k) number K871619.

Who is the listed applicant for LPM-1 (LASER POWER METER)?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LPM-1 (LASER POWER METER)?

The FDA product code for LPM-1 (LASER POWER METER) is GEX. This falls under the Gastroenterology category.

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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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