510(k) K822301
K822301 is an FDA 510(k) premarket notification submitted by Proto-Med, Inc. for the device "ROYAL 1 OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on August 19, 1982. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Proto-Med, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1982
- Date Received
- August 3, 1982
- 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