The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker 1488 Hd Video Camera With Infrared Compatibility.
| Device ID | K132785 |
| 510k Number | K132785 |
| Device Name: | STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Lifei Liu |
| Correspondent | Lifei Liu Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2013-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327363425 | K132785 | 000 |
| 07613327061086 | K132785 | 000 |
| 07613327061062 | K132785 | 000 |
| 07613327061055 | K132785 | 000 |
| 07613327061031 | K132785 | 000 |
| 07613327061024 | K132785 | 000 |
| 07613327061017 | K132785 | 000 |
| 07613327061000 | K132785 | 000 |
| 07613327057072 | K132785 | 000 |
| 07613327054675 | K132785 | 000 |
| 07613327061161 | K132785 | 000 |
| 07613327063387 | K132785 | 000 |
| 07613327063394 | K132785 | 000 |
| 07613327174861 | K132785 | 000 |
| 07613327174496 | K132785 | 000 |
| 07613327174380 | K132785 | 000 |
| 07613327063455 | K132785 | 000 |
| 07613327063448 | K132785 | 000 |
| 07613327063431 | K132785 | 000 |
| 07613327063424 | K132785 | 000 |
| 07613327063417 | K132785 | 000 |
| 07613327063400 | K132785 | 000 |
| 07613327054651 | K132785 | 000 |