510(k) K163223
K163223 is an FDA 510(k) premarket notification submitted by Isovac Products, LLC for the device "ORCA (tm) - Operational Rescue Containment Apparatus". The FDA issued a decision of Substantially Equivalent on November 2, 2017. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. Isovac Products, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2017
- Date Received
- November 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Patient Isolation
- Device Class
- Class II
- Regulation Number
- 880.5450
- Review Panel
- HO
- Submission Type