LZE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Isometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1520
- Medical specialty
- Orthopedic
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET (K950178) | Pharma-Plast Intl. A/S | 1995-07-17 | + Add |
Track LZE automatically
Every clearance here is in the API, with alerts when new ones post.