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FDA 510(k)

SDMO APPLICATOR CODE: ASN.8236

K-Number: K921961 · 1992-07-01

ApplicantMedi-Physics Inc. Dba Nycomed Amersham Imaging
Decision Date1992-07-01
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDMO APPLICATOR CODE: ASN.8236 is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. It received FDA 510(k) clearance on 1992-07-01 under 510(k) number K921961. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDMO APPLICATOR CODE: ASN.8236?

SDMO APPLICATOR CODE: ASN.8236 is a medical device that received FDA 510(k) clearance on 1992-07-01. The listed applicant is Medi-Physics Inc. Dba Nycomed Amersham Imaging. The 510(k) number is K921961.

When did SDMO APPLICATOR CODE: ASN.8236 receive FDA 510(k) clearance?

SDMO APPLICATOR CODE: ASN.8236 received FDA 510(k) clearance on 1992-07-01, under 510(k) number K921961.

Who is the listed applicant for SDMO APPLICATOR CODE: ASN.8236?

The FDA 510(k) record lists Medi-Physics Inc. Dba Nycomed Amersham Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDMO APPLICATOR CODE: ASN.8236?

The FDA product code for SDMO APPLICATOR CODE: ASN.8236 is IWJ.

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Other records listing Medi-Physics Inc. Dba Nycomed Amersham Imaging 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.

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Related Devices (Code: IWJ)

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.

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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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