510(k) K760680
K760680 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "INTERMITTENT MANDATORY VENTILATION". The FDA issued a decision of Substantially Equivalent on September 27, 1976. The device falls under product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)), a Class II device regulated under 21 CFR 868.5955. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1976
- Date Received
- September 20, 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