510(k) K914196
K914196 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "RONDEX MASKS MODELS 9015/9011/901102 MODIFIED". The FDA issued a decision of Substantially Equivalent on November 8, 1991. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1991
- Date Received
- September 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type