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FDA 510(k)

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

K-Number: K801552 · 1980-07-28

ApplicantEdwards Laboratories
Decision Date1980-07-28
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801552. 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 MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR?

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Edwards Laboratories. The 510(k) number is K801552.

When did MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR receive FDA 510(k) clearance?

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801552.

Who is the listed applicant for MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR?

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

What is the FDA product code for MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR?

The FDA product code for MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR is KRB.

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Other records listing 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.

K800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESISK781535AC ADAPTER:MODELS 9525,9526,9527

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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.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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