510(k) K874659
K874659 is an FDA 510(k) premarket notification submitted by Inhalation Plastics for the device "STERILIZATION OF DEVICES BY RADIATION". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Inhalation Plastics has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1988
- Date Received
- October 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type