The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for Springfusor 10r.
| Device ID | K910007 |
| 510k Number | K910007 |
| Device Name: | SPRINGFUSOR 10R |
| Classification | Pump, Infusion |
| Applicant | GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Contact | David Capes |
| Correspondent | David Capes GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-02 |
| Decision Date | 1993-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 9350902000419 | K910007 | 000 |
| 09350902000778 | K910007 | 000 |
| 09350902000808 | K910007 | 000 |
| 09350902000839 | K910007 | 000 |
| 09350902000860 | K910007 | 000 |
| 09350902000891 | K910007 | 000 |
| 09350902000921 | K910007 | 000 |
| 09350902000952 | K910007 | 000 |
| 09350902000983 | K910007 | 000 |
| 9350902000747 | K910007 | 000 |
| 9350902000716 | K910007 | 000 |
| 9350902000686 | K910007 | 000 |
| 9350902000440 | K910007 | 000 |
| 9350902000471 | K910007 | 000 |
| 9350902000501 | K910007 | 000 |
| 9350902000532 | K910007 | 000 |
| 9350902000563 | K910007 | 000 |
| 9350902000594 | K910007 | 000 |
| 9350902000624 | K910007 | 000 |
| 9350902000655 | K910007 | 000 |
| 09350902001010 | K910007 | 000 |
| 09350902001041 | K910007 | 000 |
| 09350902001805 | K910007 | 000 |
| 09350902001836 | K910007 | 000 |
| 09350902001867 | K910007 | 000 |
| 09350902001898 | K910007 | 000 |
| 09350902001928 | K910007 | 000 |
| 09350902001959 | K910007 | 000 |
| 09350902000365 | K910007 | 000 |
| 09350902000389 | K910007 | 000 |
| 09350902001775 | K910007 | 000 |
| 09350902001744 | K910007 | 000 |
| 09350902001713 | K910007 | 000 |
| 09350902001072 | K910007 | 000 |
| 09350902001102 | K910007 | 000 |
| 09350902001133 | K910007 | 000 |
| 9350902001508 | K910007 | 000 |
| 9350902001539 | K910007 | 000 |
| 9350902001560 | K910007 | 000 |
| 9350902001591 | K910007 | 000 |
| 09350902001638 | K910007 | 000 |
| 09350902001683 | K910007 | 000 |