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FDA 510(k)

PERINATAL COMPUTER SYS MODEL 100A & 100B

K-Number: K855044 · 1986-03-12

ApplicantPeritronics Research and Development, Inc.
Decision Date1986-03-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERINATAL COMPUTER SYS MODEL 100A & 100B is the device name listed in this FDA 510(k) record. The listed applicant is Peritronics Research and Development, Inc.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K855044. 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 PERINATAL COMPUTER SYS MODEL 100A & 100B?

PERINATAL COMPUTER SYS MODEL 100A & 100B is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Peritronics Research and Development, Inc.. The 510(k) number is K855044.

When did PERINATAL COMPUTER SYS MODEL 100A & 100B receive FDA 510(k) clearance?

PERINATAL COMPUTER SYS MODEL 100A & 100B received FDA 510(k) clearance on 1986-03-12, under 510(k) number K855044.

Who is the listed applicant for PERINATAL COMPUTER SYS MODEL 100A & 100B?

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

What is the FDA product code for PERINATAL COMPUTER SYS MODEL 100A & 100B?

The FDA product code for PERINATAL COMPUTER SYS MODEL 100A & 100B 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 Peritronics Research and Development, 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.

K870692PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085

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.

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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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