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FDA 510(k)

PICO MODELS 30, 50, 70

K-Number: K962158 · 1996-10-29

ApplicantRadiometer America, Inc.
Decision Date1996-10-29
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICO MODELS 30, 50, 70 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1996-10-29 under 510(k) number K962158. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICO MODELS 30, 50, 70?

PICO MODELS 30, 50, 70 is a medical device that received FDA 510(k) clearance on 1996-10-29. The listed applicant is Radiometer America, Inc.. The 510(k) number is K962158.

When did PICO MODELS 30, 50, 70 receive FDA 510(k) clearance?

PICO MODELS 30, 50, 70 received FDA 510(k) clearance on 1996-10-29, under 510(k) number K962158.

Who is the listed applicant for PICO MODELS 30, 50, 70?

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

What is the FDA product code for PICO MODELS 30, 50, 70?

The FDA product code for PICO MODELS 30, 50, 70 is JKA.

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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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