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FDA 510(k)

PORTAREM-3000, PFS-6000

K-Number: K964340 · 1997-01-10

ApplicantStarkey Laboratories, Inc.
Decision Date1997-01-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PORTAREM-3000, PFS-6000 is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964340. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTAREM-3000, PFS-6000?

PORTAREM-3000, PFS-6000 is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K964340.

When did PORTAREM-3000, PFS-6000 receive FDA 510(k) clearance?

PORTAREM-3000, PFS-6000 received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964340.

Who is the listed applicant for PORTAREM-3000, PFS-6000?

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

What is the FDA product code for PORTAREM-3000, PFS-6000?

The FDA product code for PORTAREM-3000, PFS-6000 is EWO.

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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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