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FDA 510(k)

CALIBRATOR, DYNAMIC

K-Number: K781692 · 1978-11-29

ApplicantWaters Assoc., Inc.
Decision Date1978-11-29
Product CodeDXM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALIBRATOR, DYNAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Waters Assoc., Inc.. It received FDA 510(k) clearance on 1978-11-29 under 510(k) number K781692. The device is classified under product code DXM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATOR, DYNAMIC?

CALIBRATOR, DYNAMIC is a medical device that received FDA 510(k) clearance on 1978-11-29. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K781692.

When did CALIBRATOR, DYNAMIC receive FDA 510(k) clearance?

CALIBRATOR, DYNAMIC received FDA 510(k) clearance on 1978-11-29, under 510(k) number K781692.

Who is the listed applicant for CALIBRATOR, DYNAMIC?

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

What is the FDA product code for CALIBRATOR, DYNAMIC?

The FDA product code for CALIBRATOR, DYNAMIC is DXM.

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Other records listing Waters Assoc., 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.

K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOLK8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATHK801852MRM-2 OXYGEN CONSUMPTION MONITORK801431PAN-AM MYELOGRAM TRAYK791661SYSTEM CONTROLLER 720 SERIESK7910264F STERILE BALLOON-LESS, CATHETER 913-28

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Related Devices (Code: DXM)

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.

K791892TAPE-A-TRACEInstromedix, Inc.

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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