510(k) K011844
K011844 is an FDA 510(k) premarket notification submitted by Merits Health Products., Inc. for the device "MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS". The FDA issued a decision of Substantially Equivalent on Aug 28, 2001. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Merits Health Products., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 28, 2001
- Date Received
- Jun 12, 2001
- Clearance Type
- Traditional
- 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)