NON STRESS TEST MONITOR 507
FDA 510(k) clearance K840285 · decided 1984-05-09
Clearance details
- K-number
- K840285
- Device name
- NON STRESS TEST MONITOR 507
- Applicant
- Imex Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-24
- Decision date
- 1984-05-09
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- HGH
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| Hysteroscopy System (K172151) | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018-04-09 |
| PANPAC DISPOSABLE VACUUM CURETTES (K161106) | Panpac Medical Corporation | 2017-01-13 |
| DISPOSABLE ENDOSCOPIC CANNULA (K140213) | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 |
| RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (K093508) | Womancare Global | 2010-03-04 |
| KOLSTER METHODS (K935820) | Kolster Methods | 1994-07-19 |
Recalls involving this device
No recalls on record reference this clearance.