510(k) K893713
K893713 is an FDA 510(k) premarket notification submitted by Nova Health Systems, Inc. for the device "NOVA OXYGEN TENT". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Nova Health Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1989
- Date Received
- May 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type