Product code LZE
- Device name
- Isometer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.1520
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950178 | PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET | Pharma-Plast Intl. A/S | 1995-07-17 |