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FDA 510(k)

MEGA AMNIOCENTESIS KIT

K-Number: K915863 · 1992-03-30

ApplicantMega Medical, Inc.
Decision Date1992-03-30
Product CodeHIO
Advisory CommitteeOB
DecisionUnknown

Device Summary

MEGA AMNIOCENTESIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mega Medical, Inc.. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K915863. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MEGA AMNIOCENTESIS KIT?

MEGA AMNIOCENTESIS KIT is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Mega Medical, Inc.. The 510(k) number is K915863.

When did MEGA AMNIOCENTESIS KIT receive FDA 510(k) clearance?

MEGA AMNIOCENTESIS KIT received FDA 510(k) clearance on 1992-03-30, under 510(k) number K915863.

Who is the listed applicant for MEGA AMNIOCENTESIS KIT?

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

What is the FDA product code for MEGA AMNIOCENTESIS KIT?

The FDA product code for MEGA AMNIOCENTESIS KIT is HIO.

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Other records listing Mega Medical, 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.

K913317MEGA ARTHROGRAM KITK913397MEGA ANGIOGRAM KITK912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KITK913382MEGA PARACENTESIS KITK912322MEGA SPINAL ANESTHESIA KITK912564MEGA PERICARDIOCENTESIS KIT

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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.K904583SONO-VU US(TM)E-Z-Em, 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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