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FDA 510(k)

SBDX MOBILE FLUOROSCOPY SYSTEM

K-Number: K953113 · 1996-03-29

ApplicantCardiac Mariners, Inc.
Decision Date1996-03-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SBDX MOBILE FLUOROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Mariners, Inc.. It received FDA 510(k) clearance on 1996-03-29 under 510(k) number K953113. 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 SBDX MOBILE FLUOROSCOPY SYSTEM?

SBDX MOBILE FLUOROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Cardiac Mariners, Inc.. The 510(k) number is K953113.

When did SBDX MOBILE FLUOROSCOPY SYSTEM receive FDA 510(k) clearance?

SBDX MOBILE FLUOROSCOPY SYSTEM received FDA 510(k) clearance on 1996-03-29, under 510(k) number K953113.

Who is the listed applicant for SBDX MOBILE FLUOROSCOPY SYSTEM?

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

What is the FDA product code for SBDX MOBILE FLUOROSCOPY SYSTEM?

The FDA product code for SBDX MOBILE FLUOROSCOPY SYSTEM is JAA.

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Other records listing Cardiac Mariners, 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.

K982345VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM

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.

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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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