The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Pocone Infrared Spectrophotometer.
| Device ID | K041148 |
| 510k Number | K041148 |
| Device Name: | POCONE INFRARED SPECTROPHOTOMETER |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair, Rac |
| Correspondent | Cynthia A Sinclair, Rac OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987035343417 | K041148 | 000 |