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FDA 510(k)

BIOMEDICS BLADDER SCANNER

K-Number: K842687 · 1985-04-08

ApplicantBiomedics
Decision Date1985-04-08
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOMEDICS BLADDER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Biomedics. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K842687. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMEDICS BLADDER SCANNER?

BIOMEDICS BLADDER SCANNER is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Biomedics. The 510(k) number is K842687.

When did BIOMEDICS BLADDER SCANNER receive FDA 510(k) clearance?

BIOMEDICS BLADDER SCANNER received FDA 510(k) clearance on 1985-04-08, under 510(k) number K842687.

Who is the listed applicant for BIOMEDICS BLADDER SCANNER?

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

What is the FDA product code for BIOMEDICS BLADDER SCANNER?

The FDA product code for BIOMEDICS BLADDER SCANNER is ITX.

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Related Devices (Code: ITX)

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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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