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FDA 510(k)

POLARIX 2 AND POLARIX 2E

K-Number: K884578 · 1989-02-09

ApplicantDyna-Med
Decision Date1989-02-09
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLARIX 2 AND POLARIX 2E is the device name listed in this FDA 510(k) record. The listed applicant is Dyna-Med. It received FDA 510(k) clearance on 1989-02-09 under 510(k) number K884578. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARIX 2 AND POLARIX 2E?

POLARIX 2 AND POLARIX 2E is a medical device that received FDA 510(k) clearance on 1989-02-09. The listed applicant is Dyna-Med. The 510(k) number is K884578.

When did POLARIX 2 AND POLARIX 2E receive FDA 510(k) clearance?

POLARIX 2 AND POLARIX 2E received FDA 510(k) clearance on 1989-02-09, under 510(k) number K884578.

Who is the listed applicant for POLARIX 2 AND POLARIX 2E?

The FDA 510(k) record lists Dyna-Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIX 2 AND POLARIX 2E?

The FDA product code for POLARIX 2 AND POLARIX 2E is JAA.

Related Clinical Trials

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.

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Other records listing Dyna-Med 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.

K884340AMX-110, AMX-II AND AMX-IIIK863504OBSTETRICAL KITK760258BITE STICK, DYNA

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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