510(k) K163277
K163277 is an FDA 510(k) premarket notification submitted by Revolutionary Medical Devices, Inc. for the device "SuperNO2VA Device". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Revolutionary Medical Devices, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2017
- Date Received
- November 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Gas, Anesthetic
- Device Class
- Class I
- Regulation Number
- 868.5550
- Review Panel
- AN
- Submission Type