The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Microspan -ph Monitor.
| Device ID | K842303 |
| 510k Number | K842303 |
| Device Name: | MICROSPAN -PH MONITOR |
| Classification | Chamber, Hyperbaric |
| Applicant | BIOCHEM INTERNATIONAL, INC. P.O. BOX 13157 Milwaukee , WI 53213 - |
| Contact | Der Ruhr |
| Correspondent | Der Ruhr BIOCHEM INTERNATIONAL, INC. P.O. BOX 13157 Milwaukee , WI 53213 - |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-11 |
| Decision Date | 1984-10-12 |