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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 the device name listed in this FDA 510(k) record. The listed applicant is Isovac Products, LLC. It received FDA 510(k) clearance on 2017-11-02 under 510(k) 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. The listed applicant is Isovac Products, LLC. The 510(k) number is K163223.

When did ORCA (tm) - Operational Rescue Containment Apparatus receive FDA 510(k) clearance?

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

Who is the listed applicant for ORCA (tm) - Operational Rescue Containment Apparatus?

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

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.

Related Devices (Code: LGM)

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.

K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc.

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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