510(k) K882817
K882817 is an FDA 510(k) premarket notification submitted by Swisco, Inc. for the device "LUNG DIFFUSION GAS MIXTURE". The FDA issued a decision of Substantially Equivalent on August 15, 1988. The device falls under product code BYK (Tent, Oxygen, Electrically Powered), a Class II device regulated under 21 CFR 868.5710. Swisco, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1988
- Date Received
- July 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Oxygen, Electrically Powered
- Device Class
- Class II
- Regulation Number
- 868.5710
- Review Panel
- AN
- Submission Type