The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Pressure Infusion Cuff.
| Device ID | K942933 |
| 510k Number | K942933 |
| Device Name: | PRESSURE INFUSION CUFF |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Contact | Yehuda Tamari |
| Correspondent | Yehuda Tamari CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1994-08-25 |