Advanced Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K955931 | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | August 14, 1996 |
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | July 18, 1995 |
| K940898 | MODEL IM77 INTRAPARTUM FETAL MONITOR | March 1, 1995 |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | July 22, 1994 |
| K932278 | PFM PROFESSIONAL 7000 SPIROMETER | December 17, 1993 |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | July 11, 1991 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | October 22, 1990 |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | January 9, 1990 |
| K891672 | PUL-TRON 100K PROFESSIONAL SPIROMETER | June 16, 1989 |
| K880756 | MODEL PM-20A PHYSIOLOGICAL MONITOR | September 27, 1988 |