510(k) K020330
K020330 is an FDA 510(k) premarket notification submitted by Pacific Consolidated Industries Llp for the device "DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)". The FDA issued a decision of Substantially Equivalent on Apr 12, 2002. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Pacific Consolidated Industries Llp has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 12, 2002
- Date Received
- Jan 31, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
- 510(k)