510(k) K062523
- Device
- TRU-MR LARYNGOSCOPE SET
- Applicant
- TRUPHATEK INTERNATIONAL, LTD.
- 510(k) number
- K062523
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-11-17
- Date received
- 2006-08-28
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 3460 Pt.e Creek Ct. #102 Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 9681384
- 3012322232
- 3006154292
- 3006061749
- 2432320
- 3002808270
- 3010726901
- 3003924186
- 9613563
- 3005536872
- 3001614464
- 3012507533
- 3011543740
- 3003435550
- 3013501110
- 3010829427
- 9617248
- 3004748541
- 3002858762
- 3020984207
- 3042888274
- 2529846
- 3032747418
- 3014023545
- 3008520150
- 3043585862
- 3042158672
- 3044186618
- 1720747
- 3006455037
- 3017166758
- 3023657851
- 3004571672
- 3013503739
- 3005067367
- 3045058049
- 9611283
- 3013901429
- 3010806653
- 3002090132
- 3007817051
- 1643116
- 3019530907
- 3024082778
- 3012002722
- 9680837
- 3002761766
- 9610531
- 1066427
- 3021477808
- 3009513193
- 8021788
- 3010707607
- 3029754081
- 3022862651
- 3022320321
- 3014656749
- 9680002
- 9680518
- 3011137372
- 9613073
- 3006513362
- 8010374
- 3009756153
- 3014680906
- 3013831261
- 3045010519
- 9611102
- 3003800159
- 3007751820
- 3003213883
- 3005450700
- 3026201231
- 3010396739
- 9616354
- 1314417
- 2022648
- 2030624
- 9611062
- 3011499367
Source Documents#
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 |
| 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 |
| K954787 | ILLUMINATOR | Hospitak, Inc. | 1996-01-31 |
Legacy Summary#
summary
FDA Review#
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