510(k) K101272
K101272 is an FDA 510(k) premarket notification submitted by Essex Industries, Inc. for the device "MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3". The FDA issued a decision of Substantially Equivalent on August 20, 2010. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Essex Industries, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2010
- Date Received
- May 6, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Liquid-Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5655
- Review Panel
- AN
- Submission Type