510(k) K922019
- Device
- LARYNGOSCOPE RIGID
- Applicant
- EASTMED ENTERPRISES INC.
- 510(k) number
- K922019
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-01-26
- Date received
- 1992-04-30
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RATHIN PUTATUNDA
- Address
- 5 Pembury Ct. Marlton NJ US 08053 08053
FDA Registration Numbers#
- 3009217531
- 3016734145
- 1222773
- 3010396739
- 3008305513
- 3010611926
- 3015398570
- 3005536872
- 3005528784
- 3001650535
- 3008338766
- 3011050570
- 3010806653
- 3013515223
- 3009538961
- 3005092287
- 3013524663
- 3017202422
- 2518436
- 3015895045
- 2936999
- 3010353847
- 3011120183
- 9610531
- 3018094310
- 3002858762
- 3002675176
- 3010455030
- 3011543740
- 8040510
- 3010726901
- 3044186618
- 3038141559
- 3009340886
- 9610773
- 3004111573
- 1643116
- 2529846
- 9611665
- 1036781
- 3014279668
- 3003032798
- 3027655341
- 3020984207
- 3001614464
- 3015512299
- 3003322138
- 3006546082
- 2085947
- 3015143057
- 3005579585
- 3008520150
- 2080783
- 9680143
- 3013901429
- 3007532396
- 3014656749
- 3021477808
- 3008693658
- 3006061749
- 9680837
- 9614084
- 3014680906
- 3011497859
- 3003431869
- 3007481893
- 3005418651
- 9610861
- 3045010519
- 3042158672
- 3004365956
- 3013735264
- 3005034064
- 3010149039
- 1519132
- 3009747810
- 1421101
- 9613073
- 3027187888
- 3006154292
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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