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FDA 510(k)

PMS AMNIOCENTESIS TRAY/KIT

K-Number: K850632 · 1985-05-22

ApplicantProfessional Medical Services
Decision Date1985-05-22
Product CodeHIO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PMS AMNIOCENTESIS TRAY/KIT is the device name listed in this FDA 510(k) record. The listed applicant is Professional Medical Services. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K850632. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMS AMNIOCENTESIS TRAY/KIT?

PMS AMNIOCENTESIS TRAY/KIT is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Professional Medical Services. The 510(k) number is K850632.

When did PMS AMNIOCENTESIS TRAY/KIT receive FDA 510(k) clearance?

PMS AMNIOCENTESIS TRAY/KIT received FDA 510(k) clearance on 1985-05-22, under 510(k) number K850632.

Who is the listed applicant for PMS AMNIOCENTESIS TRAY/KIT?

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

What is the FDA product code for PMS AMNIOCENTESIS TRAY/KIT?

The FDA product code for PMS AMNIOCENTESIS TRAY/KIT is HIO.

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Other records listing Professional Medical Services 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.

K913094DISPOSABLE SLIDE VALVE MANIFOLDK910378PRESSURE MONITORING EXTENSION LINEK904508CONDOR ANALOG INFLATION SYRINGEK904954CONDOR DIGITAL INFLATION SYRINGEK902606RADIOPAQUE RULERK884577PROCEDURE READY TRAYS

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Related Devices (Code: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, 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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