Device Type ID | 4029 |
Device Name | Micromanipulators And Microinjectors, Assisted Reproduction |
Regulation Description | Assisted Reproduction Micromanipulators And Microinjectors. |
Regulation Medical Specialty | Obstetrics/Gynecology |
Review Panel | Obstetrics/Gynecology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 884.6150 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MQJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 4029 |
Device | Micromanipulators And Microinjectors, Assisted Reproduction |
Product Code | MQJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Assisted Reproduction Micromanipulators And Microinjectors. |
CFR Regulation Number | 884.6150 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
EPPENDORF AG | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | RESEARCH INSTRUMENTS LTD - SITE B | II | Apr-28-2016 |