510(k) K895115
K895115 is an FDA 510(k) premarket notification submitted by Buttner-Frank GmbH for the device "FRANK INHALER THERMAL S". The FDA issued a decision of Substantially Equivalent on May 18, 1990. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Buttner-Frank GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1990
- Date Received
- August 15, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device Class
- Class I
- Regulation Number
- 868.5640
- Review Panel
- AN
- Submission Type