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FDA 510(k)

FETASCAN 1000, 1000A OBSTETRICAL DATA

K-Number: K813458 · 1982-01-28

ApplicantCranbury Medical Labs, Inc.
Decision Date1982-01-28
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETASCAN 1000, 1000A OBSTETRICAL DATA 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 1982-01-28 under 510(k) number K813458. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETASCAN 1000, 1000A OBSTETRICAL DATA?

FETASCAN 1000, 1000A OBSTETRICAL DATA is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Cranbury Medical Labs, Inc.. The 510(k) number is K813458.

When did FETASCAN 1000, 1000A OBSTETRICAL DATA receive FDA 510(k) clearance?

FETASCAN 1000, 1000A OBSTETRICAL DATA received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813458.

Who is the listed applicant for FETASCAN 1000, 1000A OBSTETRICAL DATA?

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

What is the FDA product code for FETASCAN 1000, 1000A OBSTETRICAL DATA?

The FDA product code for FETASCAN 1000, 1000A OBSTETRICAL DATA is HGM.

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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 800K827375BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000AK813457FETASCAN 2000,2000A OBSTETRICAL DATA

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Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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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