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FDA 510(k)

RECORDER, RE-100P HOT STYLUS STRIP CHART

K-Number: K780245 · 1978-03-27

ApplicantWaters Assoc., Inc.
Decision Date1978-03-27
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECORDER, RE-100P HOT STYLUS STRIP CHART 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 1978-03-27 under 510(k) number K780245. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECORDER, RE-100P HOT STYLUS STRIP CHART?

RECORDER, RE-100P HOT STYLUS STRIP CHART is a medical device that received FDA 510(k) clearance on 1978-03-27. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K780245.

When did RECORDER, RE-100P HOT STYLUS STRIP CHART receive FDA 510(k) clearance?

RECORDER, RE-100P HOT STYLUS STRIP CHART received FDA 510(k) clearance on 1978-03-27, under 510(k) number K780245.

Who is the listed applicant for RECORDER, RE-100P HOT STYLUS STRIP CHART?

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 RECORDER, RE-100P HOT STYLUS STRIP CHART?

The FDA product code for RECORDER, RE-100P HOT STYLUS STRIP CHART is DSF.

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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: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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