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FDA 510(k)

NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20

K-Number: K863494 · 1986-12-22

ApplicantAdvantage Medical Systems, Inc.
Decision Date1986-12-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K863494. 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 PHYSIOLOGICAL MONITOR MODEL PM 20?

NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Advantage Medical Systems, Inc.. The 510(k) number is K863494.

When did NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 receive FDA 510(k) clearance?

NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 received FDA 510(k) clearance on 1986-12-22, under 510(k) number K863494.

Who is the listed applicant for NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20?

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

What is the FDA product code for NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20?

The FDA product code for NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 is DRT.

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Other records listing Advantage Medical Systems, 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.

K873957NON-CORING HUBER TYPE NEEDLESK873290LACERATION AND INSTRUMENT TRAYSK861556MODIFIED FETAL MONITOR MODEL FM-2K861279FLUORO PLUSK861455MODEL DT-102 DATA TELEPHONE TRANSMITTERK852518MODIFICATION FETAL MONITOR MODEL FM-2

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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

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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