ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE— 510(k) K963435
Substantially EquivalentZimmer Patient Care Division
FDA 510(k) clearance K963435 for ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE, Substantially Equivalent on 1996-11-06. Applicant: Zimmer Patient Care Division. Device class: 1.
Clearance details
- Applicant
- Zimmer Patient Care Division
- Product code
- Code FMQ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6760
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dover, OH, US
Recent devices under product code FMQ
view allMore clearances from Zimmer Patient Care Division
view allAdverse events under product code FMQ
product code FMQ- Death
- 8
- Total
- 8
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.