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FDA 510(k)

SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3

K-Number: K021246 · 2002-05-13

ApplicantSensidyne, Inc.
Decision Date2002-05-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 is the device name listed in this FDA 510(k) record. The listed applicant is Sensidyne, Inc.. It received FDA 510(k) clearance on 2002-05-13 under 510(k) number K021246. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3?

SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 is a medical device that received FDA 510(k) clearance on 2002-05-13. The listed applicant is Sensidyne, Inc.. The 510(k) number is K021246.

When did SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 receive FDA 510(k) clearance?

SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 received FDA 510(k) clearance on 2002-05-13, under 510(k) number K021246.

Who is the listed applicant for SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3?

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

What is the FDA product code for SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3?

The FDA product code for SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 is DQA.

Related Clinical Trials

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Other records listing Sensidyne, Inc. 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.

K011974SENSAIDK010382100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-IK000700SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

Related Devices (Code: DQA)

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

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