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FDA 510(k)

BIOMODULE 3-M1

K-Number: K123658 · 2013-04-24

ApplicantZephyr Technology Corporation
Decision Date2013-04-24
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMODULE 3-M1 is the device name listed in this FDA 510(k) record. The listed applicant is Zephyr Technology Corporation. It received FDA 510(k) clearance on 2013-04-24 under 510(k) number K123658. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMODULE 3-M1?

BIOMODULE 3-M1 is a medical device that received FDA 510(k) clearance on 2013-04-24. The listed applicant is Zephyr Technology Corporation. The 510(k) number is K123658.

When did BIOMODULE 3-M1 receive FDA 510(k) clearance?

BIOMODULE 3-M1 received FDA 510(k) clearance on 2013-04-24, under 510(k) number K123658.

Who is the listed applicant for BIOMODULE 3-M1?

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

What is the FDA product code for BIOMODULE 3-M1?

The FDA product code for BIOMODULE 3-M1 is DRX.

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Other records listing Zephyr Technology Corporation 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.

K122763PHYSIOLOGICAL DATA PROCESSORK113045BIOHARNESSK100040BIOHARNESS

Related Devices (Code: DRX)

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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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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