510(k) K864116
K864116 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ANAGO ISOLATION MASK (#80-950)". The FDA issued a decision of Substantially Equivalent on November 25, 1986. The device falls under product code LGM (Chamber, Patient Isolation), a Class II device regulated under 21 CFR 880.5450. Anago, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1986
- Date Received
- October 21, 1986
- 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