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FDA 510(k)

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100

K-Number: K904748 · 1991-03-01

ApplicantTranstracheal Systems
Decision Date1991-03-01
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 is the device name listed in this FDA 510(k) record. The listed applicant is Transtracheal Systems. It received FDA 510(k) clearance on 1991-03-01 under 510(k) number K904748. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100?

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 is a medical device that received FDA 510(k) clearance on 1991-03-01. The listed applicant is Transtracheal Systems. The 510(k) number is K904748.

When did TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 receive FDA 510(k) clearance?

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 received FDA 510(k) clearance on 1991-03-01, under 510(k) number K904748.

Who is the listed applicant for TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100?

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

What is the FDA product code for TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100?

The FDA product code for TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 is DRG.

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Other records listing Transtracheal Systems 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.

K982943TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000K981078TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000K981080SCOOP 1K962944TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)K904749TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200K902281MODIFIED SCOOP TRANSTRACHEAL CATHETERS

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Related Devices (Code: DRG)

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

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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