HGW — Sampler, Blood, Fetal Class II
FDA product code HGW covers "Sampler, Blood, Fetal", a Class II medical device regulated under 21 CFR 884.1560. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HGW
- Device Class
- Class II
- Regulation Number
- 884.1560
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K891388 | transidyne general | 1570 - FETAL BLOOD SAMPLING KIT | March 28, 1989 |
| K884685 | a and a medical | ROCKET FETAL BLOOD SAMPLING TRAY | January 12, 1989 |
| K831459 | transidyne general | FETAL BLOOD SAMPLING KIT #1560 | June 30, 1983 |
| K810028 | transidyne general | FETAL BLOOD SAMPLING KIT MODEL 1560 | January 16, 1981 |