510(k) K063477
- Device
- NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
- Applicant
- NOVAMED, LLC
- 510(k) number
- K063477
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-09
- Date received
- 2006-11-16
- 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#
- 9610861
- 1222773
- 3004168759
- 3002761766
- 3004863697
- 3011499367
- 3003418325
- 3009217531
- 3004765453
- 3013358456
- 3014342096
- 9680143
- 3014129616
- 3010806653
- 3014680906
- 3021666757
- 3007137643
- 3007817051
- 3011120183
- 3005698350
- 1722070
- 3006546082
- 9680518
- 3000279801
- 3006513362
- 3016634868
- 3017202422
- 3002834291
- 3042158672
- 3008305513
- 8010482
- 9681384
- 3003807268
- 3013735264
- 3007481893
- 3026201231
- 8030673
- 3012104670
- 3005418651
- 9613079
- 3023657851
- 3005536872
- 9613926
- 1221826
- 3008338766
- 8043903
- 8022032
- 2025816
- 3013515223
- 3004552850
- 3007597038
- 3005273623
- 2518436
- 1928237
- 3009513193
- 3018094310
- 3017178358
- 3024026674
- 9681622
- 3012002722
- 3007421149
- 3006389770
- 3043585862
- 1417592
- 3010317211
- 1225968
- 3019784580
- 3003902679
- 9610617
- 9613563
- 3014023545
- 3013501110
- 3004111573
- 3009747810
- 3014233600
- 3003322138
- 3011371465
- 3045010519
- 3012843412
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 |
| 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 |
| K954787 | ILLUMINATOR | Hospitak, Inc. | 1996-01-31 |
Legacy Summary#
summary
FDA Review#
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