The following data is part of a premarket notification filed by Labnet Intl., Inc. with the FDA for Hermle Z230h.
| Device ID | K920207 |
| 510k Number | K920207 |
| Device Name: | HERMLE Z230H |
| Classification | Centrifuge, Hematocrit |
| Applicant | LABNET INTL., INC. P.O. BOX 841 Woodbridge, NJ 07095 |
| Contact | Walter Demsia |
| Correspondent | Walter Demsia LABNET INTL., INC. P.O. BOX 841 Woodbridge, NJ 07095 |
| Product Code | GKG |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-16 |
| Decision Date | 1992-06-09 |