GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
FDA 510(k) clearance K970619 · decided 1997-11-19
Clearance details
- K-number
- K970619
- Device name
- GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-18
- Decision date
- 1997-11-19
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- CCW
- Device class
- 1
- Regulation number
- 868.5540
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Clarence, NY, US
- Third-party review
- No
- Expedited review
- No
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| MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (K062231) | Minrad, Inc. | 2006-08-31 |
| MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (K041852) | Minrad, Inc. | 2004-11-15 |
| FLEXIBLADE (K984101) | Arco Medic , Ltd. | 1999-09-03 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (K971377) | Wilson Greatbatch Technologies, Inc. | 1998-04-30 |
| SCOPETEX(TM) (K945590) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
Recalls involving this device
No recalls on record reference this clearance.