K930012 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES K-CUFF. This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).
Submitted by Kawasumi Laboratories Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on December 14, 1993, 344 days after receiving the submission on January 4, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.
| 510(k) Number | K930012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1993 |
| Decision Date | December 14, 1993 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZD — Infusor, Pressure, For I.v. Bags |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5420 |