510(k) K062231
K062231 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001". The FDA issued a decision of Substantially Equivalent on August 31, 2006. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Minrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2006
- Date Received
- August 2, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laryngoscope, Rigid
- Device Class
- Class I
- Regulation Number
- 868.5540
- Review Panel
- AN
- Submission Type