The following data is part of a premarket notification filed by Seiichi Mfg., Inc. with the FDA for Maxi-scope Or Ultra-scope.
| Device ID | K912128 |
| 510k Number | K912128 |
| Device Name: | MAXI-SCOPE OR ULTRA-SCOPE |
| Classification | Stethoscope, Manual |
| Applicant | SEIICHI MFG., INC. 95 RIVERSIDE DR. Jamestown, KY 42629 |
| Contact | Shirley Masaoka |
| Correspondent | Shirley Masaoka SEIICHI MFG., INC. 95 RIVERSIDE DR. Jamestown, KY 42629 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-06-28 |