Mavis C
by Philips Medical Systems (Cleveland), Inc.
510(k) K813002
Mavis C is a Class II device made by Philips Medical Systems (Cleveland), Inc., cleared under FDA 510(k) K813002 on 1 Mar 1982, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813002 | Date1 Mar 1982 | StatusActive |
Official records
- FDA 510(k) database K813002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DXK (Echocardiograph).
- Del Mar Avionics 8300 Sector Imager Sys by Del Mar Avionics
- Ultra Ice Plus - Pi 9 Mhz Peripheral Imaging Catheter by Boston Scientific
- Interspec Apogee Echocardiograph by Interspec, Inc.
- High-Speed Sector Scanning SSL-52H by Toshiba Medical Systems
- Prism Software Program by Prism Imaging, Inc.
- Genesis II by Biosound, Inc.
- SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. by Sonotek Corp.
- CINE'VIEW - STRESS ECHO & IMAGE REVIEW by Prism Imaging, Inc.
- SONOLINE SX ULTRASOUND SCANNER by SIEMENS MEDICAL SOLUTIONS USA, INC.
- ECHOCARDIOGRAPHY SYS., MODEL 3860 by Honeywell, Inc.
Other devices from Philips Medical Systems (Cleveland), Inc.
See all devices from Philips Medical Systems (Cleveland), Inc. →