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FDA 510(k)

SPLASH ADAPTOR

K-Number: K853665 · 1985-10-10

ApplicantOhio Medical Research, Inc.
Decision Date1985-10-10
Product CodeBYH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPLASH ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Research, Inc.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K853665. The device is classified under product code BYH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLASH ADAPTOR?

SPLASH ADAPTOR is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Ohio Medical Research, Inc.. The 510(k) number is K853665.

When did SPLASH ADAPTOR receive FDA 510(k) clearance?

SPLASH ADAPTOR received FDA 510(k) clearance on 1985-10-10, under 510(k) number K853665.

Who is the listed applicant for SPLASH ADAPTOR?

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

What is the FDA product code for SPLASH ADAPTOR?

The FDA product code for SPLASH ADAPTOR is BYH.

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Related Devices (Code: BYH)

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.

K946057AQUALARM MOISTURE SENSOR MODEL P85000Pegasus Research Corp.K932722CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEMCarie Med-Tech Services, Inc.K921624DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITSIntertech Resources, Inc.K900047THAYER SUCTION EVACUATION CONDENSATE COLLECTIONThayer Medical Corp.K897057THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEMThayer Medical Corp.K900591VENT-TRAP CAT# WR1000Ventlab 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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