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FDA 510(k)

INVASIVE MONITORING KITS

K-Number: K832907 · 1984-01-10

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1984-01-10
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INVASIVE MONITORING KITS is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K832907. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVASIVE MONITORING KITS?

INVASIVE MONITORING KITS is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K832907.

When did INVASIVE MONITORING KITS receive FDA 510(k) clearance?

INVASIVE MONITORING KITS received FDA 510(k) clearance on 1984-01-10, under 510(k) number K832907.

Who is the listed applicant for INVASIVE MONITORING KITS?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INVASIVE MONITORING KITS?

The FDA product code for INVASIVE MONITORING KITS is DRS.

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Other records listing American Pharmaseal Div. Ahsc 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.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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