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FDA 510(k)

DATA MODULE

K-Number: K781915 · 1979-01-10

ApplicantWaters Assoc., Inc.
Decision Date1979-01-10
Product CodeKIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA MODULE 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 1979-01-10 under 510(k) number K781915. The device is classified under product code KIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA MODULE?

DATA MODULE is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K781915.

When did DATA MODULE receive FDA 510(k) clearance?

DATA MODULE received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781915.

Who is the listed applicant for DATA MODULE?

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 DATA MODULE?

The FDA product code for DATA MODULE is KIE.

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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: KIE)

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.

K964588WATERS 515 HPLC PUMP (515)Waters CorporationK935666PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMPThe Perkin-Elmer Corp.K924347WATERS(TM) 996 PDAMillipore Corp.K914841CHROMATOGRAPHY CLINICAL USE 75JQRMillipore Corp.K911299EQUIPMENT/MATERIAL DECONTAMINATING KITRohm and Haas Co.K862506THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTORMillipore Corp.

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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