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FDA 510(k)

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

K-Number: K860289 · 1986-08-25

ApplicantProfessional Health Technologies, Inc.
Decision Date1986-08-25
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Professional Health Technologies, Inc.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K860289. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER?

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Professional Health Technologies, Inc.. The 510(k) number is K860289.

When did PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER receive FDA 510(k) clearance?

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER received FDA 510(k) clearance on 1986-08-25, under 510(k) number K860289.

Who is the listed applicant for PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER?

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

What is the FDA product code for PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER?

The FDA product code for PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER is GWL.

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Related Devices (Code: GWL)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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