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FDA 510(k)

CCO SYSTEM MODEL SP1467,SP5567,SP6267

K-Number: K892941 · 1989-11-06

ApplicantSpectramed, Inc.
Decision Date1989-11-06
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CCO SYSTEM MODEL SP1467,SP5567,SP6267 is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K892941. 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 CCO SYSTEM MODEL SP1467,SP5567,SP6267?

CCO SYSTEM MODEL SP1467,SP5567,SP6267 is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Spectramed, Inc.. The 510(k) number is K892941.

When did CCO SYSTEM MODEL SP1467,SP5567,SP6267 receive FDA 510(k) clearance?

CCO SYSTEM MODEL SP1467,SP5567,SP6267 received FDA 510(k) clearance on 1989-11-06, under 510(k) number K892941.

Who is the listed applicant for CCO SYSTEM MODEL SP1467,SP5567,SP6267?

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

What is the FDA product code for CCO SYSTEM MODEL SP1467,SP5567,SP6267?

The FDA product code for CCO SYSTEM MODEL SP1467,SP5567,SP6267 is KRB.

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Other records listing Spectramed, 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

View all 13 devices →

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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