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FDA 510(k)

SONTEC II

K-Number: K844126 · 1985-07-01

ApplicantSontec, Inc.
Decision Date1985-07-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

SONTEC II is the device name listed in this FDA 510(k) record. The listed applicant is Sontec, Inc.. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K844126. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SONTEC II?

SONTEC II is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Sontec, Inc.. The 510(k) number is K844126.

When did SONTEC II receive FDA 510(k) clearance?

SONTEC II received FDA 510(k) clearance on 1985-07-01, under 510(k) number K844126.

Who is the listed applicant for SONTEC II?

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

What is the FDA product code for SONTEC II?

The FDA product code for SONTEC II is IPF.

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Related Devices (Code: IPF)

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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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