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FDA 510(k)

AQUASONIC 100 ULTRASOUND TRANS. GEL,

K-Number: K802146 · 1980-10-10

ApplicantParker Laboratories, Inc.
Decision Date1980-10-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUASONIC 100 ULTRASOUND TRANS. GEL, is the device name listed in this FDA 510(k) record. The listed applicant is Parker Laboratories, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802146. 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 AQUASONIC 100 ULTRASOUND TRANS. GEL,?

AQUASONIC 100 ULTRASOUND TRANS. GEL, is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Parker Laboratories, Inc.. The 510(k) number is K802146.

When did AQUASONIC 100 ULTRASOUND TRANS. GEL, receive FDA 510(k) clearance?

AQUASONIC 100 ULTRASOUND TRANS. GEL, received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802146.

Who is the listed applicant for AQUASONIC 100 ULTRASOUND TRANS. GEL,?

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

What is the FDA product code for AQUASONIC 100 ULTRASOUND TRANS. GEL,?

The FDA product code for AQUASONIC 100 ULTRASOUND TRANS. GEL, is IYO.

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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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