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FDA 510(k)

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A

K-Number: K827375 · 1982-07-02

ApplicantCranbury Medical Labs, Inc.
Decision Date1982-07-02
Product Code
DecisionSubstantially Equivalent

Device Summary

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A is the device name listed in this FDA 510(k) record. The listed applicant is Cranbury Medical Labs, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K827375. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A?

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Cranbury Medical Labs, Inc.. The 510(k) number is K827375.

When did BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A receive FDA 510(k) clearance?

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A received FDA 510(k) clearance on 1982-07-02, under 510(k) number K827375.

Who is the listed applicant for BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A?

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

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Other records listing Cranbury Medical Labs, 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.

K828586ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCERK822830MEDICAL LABS FETAL SCAN #1000 W/CENTRALK827718UNKNOWNK827376BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800K813457FETASCAN 2000,2000A OBSTETRICAL DATAK813458FETASCAN 1000, 1000A OBSTETRICAL DATA

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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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