AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM— 510(k) K994072
Substantially EquivalentAmylior, Inc.
FDA 510(k) clearance K994072 for AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM, Substantially Equivalent on 2000-01-13. Applicant: Amylior, Inc.. Device class: 2.
Clearance details
- Applicant
- Amylior, Inc.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Note-Dame Of Ile Perrot,Quebec, CA
Recent devices under product code ITI
view allMore clearances from Amylior, Inc.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.