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FDA 510(k)

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915

K-Number: K022565 · 2002-10-08

ApplicantStereotaxis, Inc.
Decision Date2002-10-08
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K022565. 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 TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915?

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K022565.

When did TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 receive FDA 510(k) clearance?

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 received FDA 510(k) clearance on 2002-10-08, under 510(k) number K022565.

Who is the listed applicant for TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915?

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

What is the FDA product code for TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915?

The FDA product code for TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 is JAA.

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Related Devices (Code: JAA)

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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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