510(k) K150248
- Device
- ORL Video NasoPharyngo-Larngoscope
- Applicant
- JEDMED INSTRUMENT COMPANY
- 510(k) number
- K150248
- Product code
- EQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-23
- Date received
- 2015-02-03
- Regulation
- 874.4760
- Classification name
- Laryngoscope, Nasopharyngoscope
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG PARKS
- Address
- 5416 Jedmed Ct. Saint Louis MO US 63129 63129
FDA Registration Numbers#
- 8010573
- 1926681
- 9681246
- 3011137372
- 3007532396
- 3009118476
- 3010041511
- 3002807209
- 3009010438
- 3005527904
- 3003761012
Source Documents#
Other 510(k) Records For Product Code EQN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Jedmed Instrument Co. | 2014-02-21 |
| K834172 | OP-CON SURG. INSTRUMENT #7 | Imm Enterprises , Ltd. | 1984-03-06 |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Eder Instrument Co, Inc. | 1983-09-12 |
| K830888 | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | National Medical Technology | 1983-04-27 |
| K822525 | LARYNGOSCOPES RIGID | Kelleher Corp. | 1982-09-09 |
| K821706 | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | Kelleher Corp. | 1982-06-25 |
| K821707 | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | Kelleher Corp. | 1982-06-25 |
| K821708 | NAGASHIMA LIGHT SOURCE UNIT SL-4 | Kelleher Corp. | 1982-06-25 |
| K821709 | NAGASHIMA LIGHT SOURCE UNIT SL-5 | Kelleher Corp. | 1982-06-25 |
| K821710 | NAGASHIMA NX-150F LIGHT SOURCE UNIT | Kelleher Corp. | 1982-06-25 |
| K821269 | TRACHEOSTOMY CARE TRAYS | Intermed, Inc. | 1982-05-27 |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | Machida America, Inc. | 1982-05-13 |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | Machida America, Inc. | 1982-05-13 |
| K813297 | CONPHAR LARYNGOSCOPE | Conphar, Inc. | 1982-01-22 |
Legacy Summary#
summary
FDA Review#
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