510(k) K882433
- Device
- LARYNGOSCOPE RIGID
- Applicant
- EASTMED ENTERPRISES INC.
- 510(k) number
- K882433
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-02
- Date received
- 1988-06-14
- 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#
- Contact
- SUPTII PUTATUNDA
- Address
- 5 Pembury Ct. Marlton NJ US 08053 08053
FDA Registration Numbers#
- 3021477808
- 3008693658
- 3045058049
- 9680721
- 3003882387
- 3015216264
- 9613563
- 3011120183
- 3006713849
- 9613079
- 3009703496
- 3015997711
- 3010202439
- 3045010519
- 1123137
- 9611112
- 3014579161
- 3002808270
- 9610617
- 3013515223
- 3001620590
- 3003902679
- 3009513193
- 3005216736
- 3003435550
- 3007817051
- 1221826
- 3012002722
- 1054713
- 9617248
- 3006087789
- 3002090132
- 9613910
- 8043316
- 9710567
- 3013503739
- 3029082594
- 3006513362
- 3029754081
- 3032391
- 3008520150
- 3012494290
- 3003877407
- 3006389770
- 3012445994
- 3003322138
- 3007647244
- 8022032
- 3005579585
- 3005813597
- 3036978610
- 9681246
- 3002769835
- 3004001706
- 3006546082
- 3005418651
- 8010099
- 3004608878
- 3014680906
- 3013784566
- 3003032798
- 3004748541
- 2182318
- 3004598675
- 3011497859
- 3014233600
- 1314417
- 3004863697
- 1316463
- 9611665
- 3008305513
- 3010220595
- 3008770252
- 3015398570
- 9616250
- 3008388245
- 3013247477
- 9610861
- 3014023545
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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