510(k) K882396
K882396 is an FDA 510(k) premarket notification submitted by Viratek, Inc. for the device "AEROSOL DELIVERY HOOD". The FDA issued a decision of Substantially Equivalent on August 1, 1988. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Viratek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1988
- Date Received
- June 10, 1988
- 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