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FDA 510(k)

POSEIDON CARDIAC MONITORING SYSTEM (PCMS)

K-Number: K964408 · 1997-07-23

ApplicantInstromedix, Inc.
Decision Date1997-07-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POSEIDON CARDIAC MONITORING SYSTEM (PCMS) is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K964408. 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 POSEIDON CARDIAC MONITORING SYSTEM (PCMS)?

POSEIDON CARDIAC MONITORING SYSTEM (PCMS) is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Instromedix, Inc.. The 510(k) number is K964408.

When did POSEIDON CARDIAC MONITORING SYSTEM (PCMS) receive FDA 510(k) clearance?

POSEIDON CARDIAC MONITORING SYSTEM (PCMS) received FDA 510(k) clearance on 1997-07-23, under 510(k) number K964408.

Who is the listed applicant for POSEIDON CARDIAC MONITORING SYSTEM (PCMS)?

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

What is the FDA product code for POSEIDON CARDIAC MONITORING SYSTEM (PCMS)?

The FDA product code for POSEIDON CARDIAC MONITORING SYSTEM (PCMS) is DPS.

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Other records listing Instromedix, 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.

K964036CARDIOMAGIC 2000 SOFTWAREK955060ACCELERATED TRANSMISSION PROTOCOLK951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERK945476HEARTHWATCH III(TM)K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTSK944362HEARTCARD CARDIAC EVENT MONITOR

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Related Devices (Code: DPS)

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.

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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