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FDA 510(k)

PS-41 6M PATIENT SIMULATOR

K-Number: K963198 · 1997-03-05

ApplicantMetron U.S., Inc.
Decision Date1997-03-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PS-41 6M PATIENT SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Metron U.S., Inc.. It received FDA 510(k) clearance on 1997-03-05 under 510(k) number K963198. 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 PS-41 6M PATIENT SIMULATOR?

PS-41 6M PATIENT SIMULATOR is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is Metron U.S., Inc.. The 510(k) number is K963198.

When did PS-41 6M PATIENT SIMULATOR receive FDA 510(k) clearance?

PS-41 6M PATIENT SIMULATOR received FDA 510(k) clearance on 1997-03-05, under 510(k) number K963198.

Who is the listed applicant for PS-41 6M PATIENT SIMULATOR?

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

What is the FDA product code for PS-41 6M PATIENT SIMULATOR?

The FDA product code for PS-41 6M PATIENT SIMULATOR is DPS.

Related Clinical Trials

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.

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Other records listing Metron U.S., 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.

K982020METRON QA-IDS I.V. PUMP TESTERK973991METRON QA-510 SPO2 ANALYZERK963190QA-40M DEFIBRILLATOR TESTER

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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