The following data is part of a premarket notification filed by Bar Med Pty Ltd. with the FDA for Portable Limb Load Monitor (bmllm-100).
| Device ID | K915326 |
| 510k Number | K915326 |
| Device Name: | PORTABLE LIMB LOAD MONITOR (BMLLM-100) |
| Classification | Transducer, Miniature Pressure |
| Applicant | BAR MED PTY LTD. P.O. BOX 1090 COLLINGWOOD, VICTORIA, 3066 Australia, AU |
| Contact | Peter Barrett |
| Correspondent | Peter Barrett BAR MED PTY LTD. P.O. BOX 1090 COLLINGWOOD, VICTORIA, 3066 Australia, AU |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-22 |
| Decision Date | 1992-10-20 |