The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Microsensor Intracranial Pressure Transducer.
| Device ID | K914479 |
| 510k Number | K914479 |
| Device Name: | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Thomas J Courage |
| Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1994-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780520504 | K914479 | 000 |
| 20886704042324 | K914479 | 000 |
| 20886704042317 | K914479 | 000 |
| 20886704042287 | K914479 | 000 |
| 20886704042270 | K914479 | 000 |
| 10886704071310 | K914479 | 000 |
| 10886704042303 | K914479 | 000 |
| 10886704042266 | K914479 | 000 |
| 10886704042259 | K914479 | 000 |
| 10886704042242 | K914479 | 000 |
| 20886704042386 | K914479 | 000 |
| 10381780520337 | K914479 | 000 |
| 10381780520429 | K914479 | 000 |
| 10381780520412 | K914479 | 000 |
| 10381780520405 | K914479 | 000 |
| 10381780520382 | K914479 | 000 |
| 10381780520375 | K914479 | 000 |
| 10381780520368 | K914479 | 000 |
| 10381780520320 | K914479 | 000 |
| 10381780520351 | K914479 | 000 |
| 10381780520344 | K914479 | 000 |
| 10886704042235 | K914479 | 000 |