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FDA 510(k)

FETAL CARE MONITOR ANTEPARTUM 1500

K-Number: K871082 · 1987-08-04

ApplicantPie Data Medical BV
Decision Date1987-08-04
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL CARE MONITOR ANTEPARTUM 1500 is the device name listed in this FDA 510(k) record. The listed applicant is Pie Data Medical BV. It received FDA 510(k) clearance on 1987-08-04 under 510(k) number K871082. 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 FETAL CARE MONITOR ANTEPARTUM 1500?

FETAL CARE MONITOR ANTEPARTUM 1500 is a medical device that received FDA 510(k) clearance on 1987-08-04. The listed applicant is Pie Data Medical BV. The 510(k) number is K871082.

When did FETAL CARE MONITOR ANTEPARTUM 1500 receive FDA 510(k) clearance?

FETAL CARE MONITOR ANTEPARTUM 1500 received FDA 510(k) clearance on 1987-08-04, under 510(k) number K871082.

Who is the listed applicant for FETAL CARE MONITOR ANTEPARTUM 1500?

The FDA 510(k) record lists Pie Data Medical BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETAL CARE MONITOR ANTEPARTUM 1500?

The FDA product code for FETAL CARE MONITOR ANTEPARTUM 1500 is HGM.

Related Clinical Trials

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.

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Other records listing Pie Data Medical BV 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.

K874192MULTIPURPOSE TRANSDUCER RANGEK870653ULTRASOUND LINEAR/SECTOR SCANNER 1100K870058PIE MEDICAL SCANNER 1000K874081ENTERSCAN

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

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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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