510(k) K760263
K760263 is an FDA 510(k) premarket notification submitted by Foregger for the device "I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)), a Class II device regulated under 21 CFR 868.5955. Foregger has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1976
- Date Received
- July 21, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Intermittent Mandatory Ventilation (Imv)
- Device Class
- Class II
- Regulation Number
- 868.5955
- Review Panel
- AN
- Submission Type