510(k) K850978
- Device
- OLYMPUS LF-1 INTUBATION SCOPE
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K850978
- Product code
- CAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-23
- Date received
- 1985-03-08
- Regulation
- 868.5530
- Classification name
- Laryngoscope, Non-rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY J HARTL
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3003782610
- 3002675176
- 9680411
- 3002761766
- 3024026674
- 3015139770
- 3008439484
- 3030516433
- 3011137372
- 9610877
- 3012445994
- 3020984207
- 9610617
- 3010202439
- 2020550
- 9680304
- 3021031769
- 8040278
- 2022648
- 3010041511
- 3021010418
- 3005216736
- 8010482
- 3014342096
- 1221826
- 8040263
- 3015398570
- 3004644065
- 3009420598
- 3007127332
- 2244478
- 3015143057
- 3005273623
- 3007597038
- 3003882387
- 3011543740
- 3015925378
- 3014605202
- 3016634868
- 3030656972
- 3003759558
- 3012797688
- 3013528571
- 3010396739
- 9617248
- 3010707607
- 3009255580
- 3027655341
- 3014233600
- 3006513362
- 3004365956
- 3033010858
- 9614069
- 3016965929
- 3007532396
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951194 | FI-10M | Pentax Precision Instrument Corp. | 1995-04-06 |
| K951195 | FI-10P | Pentax Precision Instrument Corp. | 1995-04-06 |
| K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | Haemonetics Corp. | 1988-01-11 |
| K852994 | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 | Reichert-Jung, Inc. | 1985-07-29 |
| K802331 | AO FLEXIBLE LARYNGOSCOPE, #LS-7 | American Optical Corp. | 1980-10-10 |
| K801364 | AO STYLET LARYNGOSCOPE MODEL SLS | American Optical Corp. | 1980-06-17 |
| K791634 | AO STYLET LARYNGOSCOPE, MODEL SLS-1 | American Optical Corp. | 1979-09-17 |
Legacy Summary#
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FDA Review#
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