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FDA 510(k)

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM

K-Number: K965008 · 1997-12-16

ApplicantSpacelabs Medical, Inc.
Decision Date1997-12-16
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K965008. 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 BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM?

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K965008.

When did BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 1997-12-16, under 510(k) number K965008.

Who is the listed applicant for BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM?

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

What is the FDA product code for BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM?

The FDA product code for BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM is HGM.

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Other records listing Spacelabs Medical, Inc. as applicant

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Related Devices (Code: HGM)

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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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