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FDA 510(k)

RATEMINDER III INFUSION DEVICE

K-Number: K855000 · 1986-02-12

ApplicantAmerican Edwards Laboratories
Decision Date1986-02-12
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RATEMINDER III INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K855000. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RATEMINDER III INFUSION DEVICE?

RATEMINDER III INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is American Edwards Laboratories. The 510(k) number is K855000.

When did RATEMINDER III INFUSION DEVICE receive FDA 510(k) clearance?

RATEMINDER III INFUSION DEVICE received FDA 510(k) clearance on 1986-02-12, under 510(k) number K855000.

Who is the listed applicant for RATEMINDER III INFUSION DEVICE?

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

What is the FDA product code for RATEMINDER III INFUSION DEVICE?

The FDA product code for RATEMINDER III INFUSION DEVICE is LDR.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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