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FDA 510(k)

NEONATAL METASCOPE

K-Number: K903959 · 1990-11-23

ApplicantCybermedic, Inc.
Decision Date1990-11-23
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL METASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cybermedic, Inc.. It received FDA 510(k) clearance on 1990-11-23 under 510(k) number K903959. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL METASCOPE?

NEONATAL METASCOPE is a medical device that received FDA 510(k) clearance on 1990-11-23. The listed applicant is Cybermedic, Inc.. The 510(k) number is K903959.

When did NEONATAL METASCOPE receive FDA 510(k) clearance?

NEONATAL METASCOPE received FDA 510(k) clearance on 1990-11-23, under 510(k) number K903959.

Who is the listed applicant for NEONATAL METASCOPE?

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

What is the FDA product code for NEONATAL METASCOPE?

The FDA product code for NEONATAL METASCOPE is BZK.

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Other records listing Cybermedic, 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.

K941813VENSHIELDK914205PFF-1K884910MODEL 1010, CY-METK861418SPINNAKERK851197CYBERMEDIC CM-810 BODY PLETHYSMOGRAPHK842782PHYSIOLOGICAL ANALYZER CM-710

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Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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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