510(k) K840285
- Device
- NON STRESS TEST MONITOR 507
- Applicant
- IMEX MEDICAL SYSTEMS, INC.
- 510(k) number
- K840285
- Product code
- HGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-09
- Date received
- 1984-01-24
- Regulation
- 884.5070
- Classification name
- Cannula, Suction, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8044099
- 3008007615
- 3011219572
- 3014615028
- 1450908
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018-04-09 |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | 2017-01-13 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Womancare Global | 2010-03-04 |
| K935820 | KOLSTER METHODS | Kolster Methods | 1994-07-19 |
Legacy Summary#
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FDA Review#
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