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FDA 510(k)

AMBIVASON DR-200

K-Number: K800096 · 1980-02-11

ApplicantKt Medical, Inc.
Decision Date1980-02-11
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMBIVASON DR-200 is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K800096. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBIVASON DR-200?

AMBIVASON DR-200 is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800096.

When did AMBIVASON DR-200 receive FDA 510(k) clearance?

AMBIVASON DR-200 received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800096.

Who is the listed applicant for AMBIVASON DR-200?

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

What is the FDA product code for AMBIVASON DR-200?

The FDA product code for AMBIVASON DR-200 is JAF.

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Other records listing Kt Medical, 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.

K800653SINVISION LINEAR ARRAY REAL TIMEK800652MODEL E03 ECHO-OPTHALMOSCOPEK8001014200 ME ECHOENCEPHALOGRAPHK800092COMBISON COMPUTERK800099INTRACULA IIK8001007200 MA ECHO-OPHTHALMOSCOPE

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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