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FDA 510(k)

NEONATAL MONITOR 309

K-Number: K850407 · 1985-04-18

ApplicantRigel Medical Electronics, Inc.
Decision Date1985-04-18
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEONATAL MONITOR 309 is the device name listed in this FDA 510(k) record. The listed applicant is Rigel Medical Electronics, Inc.. It received FDA 510(k) clearance on 1985-04-18 under 510(k) number K850407. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL MONITOR 309?

NEONATAL MONITOR 309 is a medical device that received FDA 510(k) clearance on 1985-04-18. The listed applicant is Rigel Medical Electronics, Inc.. The 510(k) number is K850407.

When did NEONATAL MONITOR 309 receive FDA 510(k) clearance?

NEONATAL MONITOR 309 received FDA 510(k) clearance on 1985-04-18, under 510(k) number K850407.

Who is the listed applicant for NEONATAL MONITOR 309?

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

What is the FDA product code for NEONATAL MONITOR 309?

The FDA product code for NEONATAL MONITOR 309 is DRT.

Related Clinical Trials

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Other records listing Rigel Medical Electronics, 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.

K884645PATIENT MONITOR RIGEL MODEL MULTICARE 429K875160RIGEL MODEL MULTICARE 409K850156ECG PATIENT MONITOR 301K850155ECG PATIENT MONITOR 302K843376ECG PATIENT MONITOR

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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