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FDA 510(k)

HIMOBILIX 2N

K-Number: K883161 · 1988-10-21

ApplicantBay X-Ray, Inc.
Decision Date1988-10-21
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIMOBILIX 2N is the device name listed in this FDA 510(k) record. The listed applicant is Bay X-Ray, Inc.. It received FDA 510(k) clearance on 1988-10-21 under 510(k) number K883161. 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 HIMOBILIX 2N?

HIMOBILIX 2N is a medical device that received FDA 510(k) clearance on 1988-10-21. The listed applicant is Bay X-Ray, Inc.. The 510(k) number is K883161.

When did HIMOBILIX 2N receive FDA 510(k) clearance?

HIMOBILIX 2N received FDA 510(k) clearance on 1988-10-21, under 510(k) number K883161.

Who is the listed applicant for HIMOBILIX 2N?

The FDA 510(k) record lists Bay X-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIMOBILIX 2N?

The FDA product code for HIMOBILIX 2N 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 Bay X-Ray, 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.

K883160CATAPULT BUCKY (KATAPULT BLENDA)K883155RASTIX X-RAY TABLEK883153UNDISTAT WITH EXPLORATOR 35 (UCS 35E)K883162TELESTATIX X-RAY TABLEK883154SELDIX 325 TWO PULSE GENERATOR/CONTROL

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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