510(k) K833055
- Device
- LARYNGOSCOPE BLADES/HANDLES & LAMPS
- Applicant
- MEDOVATIONS, INC.
- 510(k) number
- K833055
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-14
- Date received
- 1983-09-07
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1123137
- 3007123908
- 3004215117
- 3009703496
- 3032391
- 3005034064
- 8010099
- 3009420598
- 3015173212
- 2030624
- 3012797688
- 3010455030
- 3010220595
- 3027655341
- 3009560891
- 3013831261
- 3001620590
- 8010704
- 3015351976
- 3016734145
- 3020984207
- 3027847726
- 3002858762
- 3010726901
- 3014908171
- 3008388245
- 3009747810
- 2529846
- 3036978610
- 8040884
- 3004765453
- 3031564283
- 2432320
- 3030839824
- 3042158672
- 3024026674
- 3013557562
- 9616250
- 3012445994
- 3007137643
- 1417592
- 3014023545
- 3016195092
- 3019404837
- 3011499367
- 3003334541
- 3015143057
- 3006087789
- 8010939
- 3016634868
- 3006154292
- 9681384
- 9617248
- 8040510
- 3015512299
- 3004748541
- 3002769835
- 9680721
- 3011120183
- 1412854
- 3010317211
- 9680002
- 1225968
- 9611102
- 3010272829
- 2030745
- 3003213883
- 3005418651
- 3003898360
- 3019530907
- 3030446844
- 3018094310
- 3043585862
- 3004608878
- 3042888274
- 3022862651
- 9681246
- 3033010858
- 9611112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 |
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | 2017-06-22 |
| K140951 | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | 2014-11-10 |
| K121378 | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | 2012-06-21 |
| K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | 2007-02-09 |
| K062523 | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | 2006-11-17 |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Minrad, Inc. | 2006-08-31 |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Minrad, Inc. | 2006-08-31 |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Minrad, Inc. | 2004-11-15 |
| K984101 | FLEXIBLADE | Arco Medic , Ltd. | 1999-09-03 |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | 1998-04-30 |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | Wilson Greatbatch Technologies, Inc. | 1997-11-19 |
| K945590 | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
| K961832 | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | 1996-09-06 |
| K945301 | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | 1996-05-31 |
Legacy Summary#
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FDA Review#
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