The following data is part of a premarket notification filed by Getinge Usa, Inc with the FDA for Biosign Ssi Biological Test Pack With Instant Readout Integrator.
| Device ID | K031647 |
| 510k Number | K031647 |
| Device Name: | BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Karla Byrne |
| Correspondent | Karla Byrne GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-07-29 |
| Summary: | summary |