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FDA 510(k)

CARDIOCAP II TM CH-RESP MONITORS

K-Number: K904355 · 1991-05-23

ApplicantInstrumentarium Corp.
Decision Date1991-05-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCAP II TM CH-RESP MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K904355. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCAP II TM CH-RESP MONITORS?

CARDIOCAP II TM CH-RESP MONITORS is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Instrumentarium Corp.. The 510(k) number is K904355.

When did CARDIOCAP II TM CH-RESP MONITORS receive FDA 510(k) clearance?

CARDIOCAP II TM CH-RESP MONITORS received FDA 510(k) clearance on 1991-05-23, under 510(k) number K904355.

Who is the listed applicant for CARDIOCAP II TM CH-RESP MONITORS?

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

What is the FDA product code for CARDIOCAP II TM CH-RESP MONITORS?

The FDA product code for CARDIOCAP II TM CH-RESP MONITORS is DPS.

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Other records listing Instrumentarium Corp. as applicant

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Related Devices (Code: DPS)

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K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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