Advanced Medical Systems, Inc.
Hamden, CT, US
Advanced Medical Systems, Inc. appears in FDA device records in Hamden, CT. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Advanced Medical Systems, Inc. between 1988 and 1996. The busiest year on record is 1990, with 2. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955931 | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | HGM | Substantially Equivalent | |
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | HGL | Substantially Equivalent | |
| K940898 | MODEL IM77 INTRAPARTUM FETAL MONITOR | HGM | Substantially Equivalent | |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | HGL | Substantially Equivalent | |
| K932278 | PFM PROFESSIONAL 7000 SPIROMETER | BTY | Substantially Equivalent | |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | HGP | Substantially Equivalent | |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | HEK | Substantially Equivalent | |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | KPQ | Substantially Equivalent | |
| K891672 | PUL-TRON 100K PROFESSIONAL SPIROMETER | BZG | Substantially Equivalent | |
| K880756 | MODEL PM-20A PHYSIOLOGICAL MONITOR | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain