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FDA 510(k)

TELEPHONE RECEIVERS R101 R111

K-Number: K840032 · 1984-10-26

ApplicantBiometric Products, Inc.
Decision Date1984-10-26
Product CodeDXH
Advisory CommitteeCV
DecisionUnknown

Device Summary

TELEPHONE RECEIVERS R101 R111 is the device name listed in this FDA 510(k) record. The listed applicant is Biometric Products, Inc.. It received FDA 510(k) clearance on 1984-10-26 under 510(k) number K840032. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Unknown.

Frequently Asked Questions

What is the TELEPHONE RECEIVERS R101 R111?

TELEPHONE RECEIVERS R101 R111 is a medical device that received FDA 510(k) clearance on 1984-10-26. The listed applicant is Biometric Products, Inc.. The 510(k) number is K840032.

When did TELEPHONE RECEIVERS R101 R111 receive FDA 510(k) clearance?

TELEPHONE RECEIVERS R101 R111 received FDA 510(k) clearance on 1984-10-26, under 510(k) number K840032.

Who is the listed applicant for TELEPHONE RECEIVERS R101 R111?

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

What is the FDA product code for TELEPHONE RECEIVERS R101 R111?

The FDA product code for TELEPHONE RECEIVERS R101 R111 is DXH. This falls under the Hematology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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