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FDA 510(k)

SHUNT ADAPTER

K-Number: K813428 · 1981-12-31

ApplicantQuinton, Inc.
Decision Date1981-12-31
Product CodeFKN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHUNT ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813428. The device is classified under product code FKN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUNT ADAPTER?

SHUNT ADAPTER is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Quinton, Inc.. The 510(k) number is K813428.

When did SHUNT ADAPTER receive FDA 510(k) clearance?

SHUNT ADAPTER received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813428.

Who is the listed applicant for SHUNT ADAPTER?

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

What is the FDA product code for SHUNT ADAPTER?

The FDA product code for SHUNT ADAPTER is FKN.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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Related Devices (Code: FKN)

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.

K893478DA-16 AND DA-24 SHUNT ADAPTERSAkcess Medical Products, Inc.K892667SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313Akcess Medical Products, Inc.K771425A-V SHUNT EXTENSIONQuinton, Inc.

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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