The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ust-5268p-5 Transducer.
| Device ID | K950607 |
| 510k Number | K950607 |
| Device Name: | UST-5268P-5 TRANSDUCER |
| Classification | Manometer, Blood-pressure, Venous |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | KRK |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-09-15 |