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FDA 510(k)

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

K-Number: K120253 · 2012-07-16

ApplicantElcam Medical Acal
Decision Date2012-07-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2012-07-16 under 510(k) number K120253. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)?

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) is a medical device that received FDA 510(k) clearance on 2012-07-16. The listed applicant is Elcam Medical Acal. The 510(k) number is K120253.

When did ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) receive FDA 510(k) clearance?

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) received FDA 510(k) clearance on 2012-07-16, under 510(k) number K120253.

Who is the listed applicant for ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)?

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

What is the FDA product code for ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)?

The FDA product code for ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) is DRG.

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Other records listing Elcam Medical Acal as applicant

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Related Devices (Code: DRG)

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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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