Device Type ID | 3995 |
Device Name | Table, Obstetric (and Accessories) |
Regulation Description | Obstetric Table And Accessories. |
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 | 884.4900 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KNC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3995 |
Device | Table, Obstetric (and Accessories) |
Product Code | KNC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Obstetric Table And Accessories. |
CFR Regulation Number | 884.4900 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Hill-Rom, Inc. | II | Sep-08-2016 |
2 | Hill-Rom, Inc. | II | Sep-01-2014 |