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FDA 510(k)

ORCA (tm) - Operational Rescue Containment Apparatus

K-Number: K163223 · 2017-11-02

ApplicantIsovac Products, LLC
Decision Date2017-11-02
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ORCA (tm) - Operational Rescue Containment Apparatus is a medical device manufactured by Isovac Products, LLC. It received FDA 510(k) clearance on 2017-11-02 under approval number K163223. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORCA (tm) - Operational Rescue Containment Apparatus?

ORCA (tm) - Operational Rescue Containment Apparatus is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Isovac Products, LLC. The 510(k) number is K163223.

When was ORCA (tm) - Operational Rescue Containment Apparatus approved by the FDA?

ORCA (tm) - Operational Rescue Containment Apparatus received FDA 510(k) clearance on 2017-11-02, under approval number K163223.

What company makes ORCA (tm) - Operational Rescue Containment Apparatus?

ORCA (tm) - Operational Rescue Containment Apparatus is manufactured by Isovac Products, LLC.

What is the FDA product code for ORCA (tm) - Operational Rescue Containment Apparatus?

The FDA product code for ORCA (tm) - Operational Rescue Containment Apparatus is LGM.

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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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