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FDA 510(k)

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.

K-Number: K893476 · 1989-06-23

ApplicantAndros Analyzers, Inc.
Decision Date1989-06-23
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. is the device name listed in this FDA 510(k) record. The listed applicant is Andros Analyzers, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893476. 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 ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.?

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Andros Analyzers, Inc.. The 510(k) number is K893476.

When did ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. receive FDA 510(k) clearance?

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893476.

Who is the listed applicant for ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.?

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

What is the FDA product code for ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.?

The FDA product code for ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. is JAA.

Related Clinical Trials

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Other records listing Andros Analyzers, 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.

K903806ANGIOTEC IMAGE MANAGEMENT SYSTEMK892869ANGIOTEC ZX DIGITAL IMAGE PROCESSORK891485ANGIOTEC FMX-2220 SYSTEMK852463ANDROS ANALYZERS AIRWAY ADAPTER

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

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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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