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FDA 510(k)

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

K-Number: K936182 · 1994-03-25

ApplicantOhmeda Medical
Decision Date1994-03-25
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K936182. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT?

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Ohmeda Medical. The 510(k) number is K936182.

When did CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT receive FDA 510(k) clearance?

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT received FDA 510(k) clearance on 1994-03-25, under 510(k) number K936182.

Who is the listed applicant for CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT?

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

What is the FDA product code for CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT?

The FDA product code for CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT is KRB.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K915627PACEVIEWMicromedical Industries, Ltd.

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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