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FDA 510(k)

LEFF STETHOSCOPE FOR FETAL HEART

K-Number: K761338 · 1977-01-12

ApplicantJ. Sklar Mfg. Co., Inc.
Decision Date1977-01-12
Product CodeHGN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEFF STETHOSCOPE FOR FETAL HEART is the device name listed in this FDA 510(k) record. The listed applicant is J. Sklar Mfg. Co., Inc.. It received FDA 510(k) clearance on 1977-01-12 under 510(k) number K761338. The device is classified under product code HGN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEFF STETHOSCOPE FOR FETAL HEART?

LEFF STETHOSCOPE FOR FETAL HEART is a medical device that received FDA 510(k) clearance on 1977-01-12. The listed applicant is J. Sklar Mfg. Co., Inc.. The 510(k) number is K761338.

When did LEFF STETHOSCOPE FOR FETAL HEART receive FDA 510(k) clearance?

LEFF STETHOSCOPE FOR FETAL HEART received FDA 510(k) clearance on 1977-01-12, under 510(k) number K761338.

Who is the listed applicant for LEFF STETHOSCOPE FOR FETAL HEART?

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

What is the FDA product code for LEFF STETHOSCOPE FOR FETAL HEART?

The FDA product code for LEFF STETHOSCOPE FOR FETAL HEART is HGN.

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Other records listing J. Sklar Mfg. Co., 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.

K843693JACOBS HIGH VACUUM SUCTION UNIT 05-2570K842112TISCHLER CERVICAL BIOPSY PUNCH FORCEPSK842111KOGAN ENDOSPECULUM 9-1/2K822448SCISSORS, VARIOUSK802458KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611K802457KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610

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Related Devices (Code: HGN)

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.

K813298CONPHAR DELEE HILLIS STETHOSCOPEConphar, 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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