The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Gould Xcaliber.
| Device ID | K862344 |
| 510k Number | K862344 |
| Device Name: | GOULD XCALIBER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Klyzeiko |
| Correspondent | Klyzeiko BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007188 | K862344 | 000 |