510(k) K983219
K983219 is an FDA 510(k) premarket notification submitted by Drager, Inc. for the device "NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900". The FDA issued a decision of Substantially Equivalent on December 7, 1998. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Drager, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1998
- Date Received
- September 14, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type