ENDOSTROBOSCOPE IV
FDA 510(k) clearance K884933 · decided 1989-02-15
Clearance details
- K-number
- K884933
- Device name
- ENDOSTROBOSCOPE IV
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-28
- Decision date
- 1989-02-15
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- EQL
- Device class
- 1
- Regulation number
- 874.4750
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (K984521) | Richard Wolf Medical Instruments Corp. | 1999-03-17 |
| 9105 RIGID TELESCOPIC ENDOSCOPE (K921285) | Kay Elemetrics Corp. | 1992-05-28 |
| RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (K921184) | Kay Elemetrics Corp. | 1992-05-28 |
| RHINO-LARYNX STROBOSCOPE TYPE 4914 (K842090) | Bruel & Kjaer Industri A/S | 1984-07-18 |
| LARYNGOSTROBOSCOPE (K822523) | Kelleher Corp. | 1982-09-09 |
| PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (K801866) | Pentax Precision Instrument Corp. | 1980-09-16 |
| STOCKINGS, RVS TM (K770466) | Parke-Davis Co. | 1977-03-28 |
Recalls involving this device
No recalls on record reference this clearance.