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FDA 510(k)

CILCO/UNITED SONICS PHACE PF-9000

K-Number: K851209 · 1985-05-31

ApplicantUnited Sonics, Inc.
Decision Date1985-05-31
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CILCO/UNITED SONICS PHACE PF-9000 is the device name listed in this FDA 510(k) record. The listed applicant is United Sonics, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K851209. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CILCO/UNITED SONICS PHACE PF-9000?

CILCO/UNITED SONICS PHACE PF-9000 is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is United Sonics, Inc.. The 510(k) number is K851209.

When did CILCO/UNITED SONICS PHACE PF-9000 receive FDA 510(k) clearance?

CILCO/UNITED SONICS PHACE PF-9000 received FDA 510(k) clearance on 1985-05-31, under 510(k) number K851209.

Who is the listed applicant for CILCO/UNITED SONICS PHACE PF-9000?

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

What is the FDA product code for CILCO/UNITED SONICS PHACE PF-9000?

The FDA product code for CILCO/UNITED SONICS PHACE PF-9000 is HQC.

Related Clinical Trials

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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Other records listing United Sonics, Inc. as applicant

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.

K851211PHACO PAK IK851210UNITED SONICS PHACO MODULE, DF-35K851212UNITED SONICS PACO SYSTEM MODEL 3000K851298MID LABS MVSXI

Related Devices (Code: HQC)

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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