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#
- 3022862651
- 3004571672
- 3006786907
- 8040884
- 1926681
- 1036781
- 3016734145
- 3015216264
- 3005813597
- 1720747
- 3003418325
- 3010676356
- 8010298
- 9611062
- 3008520150
- 9616250
- 3012445994
- 8040278
- 3027187888
- 3004598675
- 3009513193
- 9614093
- 3007123908
- 9613926
- 3000126234
- 9610691
- 3010317211
- 3005418651
- 3004111573
- 3030516433
- 3024026674
- 3015997711
- 3003435550
- 8021788
- 3012002722
- 3004608878
- 3014279668
- 9680837
- 1125612
- 3005034064
- 3005092287
- 3011497859
- 3009217531
- 3027655341
- 9710567
- 3010149039
- 1314417
- 2030745
- 8040510
- 3003213883
- 3003644849
- 3012494290
- 3003902679
- 3005216736
- 3025349182
- 1000379039
- 3010806653
- 2529846
- 8043316
- 3011499367
- 3009420598
- 8010939
- 3000279801
- 3023657851
- 3009538961
- 3020984207
- 3002808270
- 3010683054
- 1928237
- 8010704
- 3027556548
- 3012104670
- 8030673
- 9615393
- 3013557562
- 3006546082
- 3003334541
- 3010272829
- 3016965929
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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