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FDA 510(k)

DISPOSABLE TRANSDUCER DOMES & KITS

K-Number: K821894 · 1982-07-20

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1982-07-20
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TRANSDUCER DOMES & 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 1982-07-20 under 510(k) number K821894. 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 DISPOSABLE TRANSDUCER DOMES & KITS?

DISPOSABLE TRANSDUCER DOMES & KITS is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K821894.

When did DISPOSABLE TRANSDUCER DOMES & KITS receive FDA 510(k) clearance?

DISPOSABLE TRANSDUCER DOMES & KITS received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821894.

Who is the listed applicant for DISPOSABLE TRANSDUCER DOMES & 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 DISPOSABLE TRANSDUCER DOMES & KITS?

The FDA product code for DISPOSABLE TRANSDUCER DOMES & KITS is DRS.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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K874022PHARMASEAL WOUND IRRIGATION DEVICEK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK874517PHARMASEAL RUBBER URETHRAL CATHETERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: DRS)

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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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