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B4C System Sensor User Guide
B4C System - Sensor User Guide
warnings and precautions
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(v. 9)
Oct 06, 2021 20:17
Updated precaution statement per FDA request on 10/6 to change "predicted value" to "estimated value"
v. 8
Oct 06, 2021 20:10
Moved earlier in document per FDA request on 10/6. Removed previous section number 3.2 based on updated placement
v. 7
Oct 06, 2021 20:03
Revised warning with wording from FDA that device has not been validated as substitute for invasive ICP monitoring methods
v. 6
Aug 28, 2021 14:41
v. 5
Aug 18, 2021 10:00
v. 4
Aug 17, 2021 23:56
v. 3
Aug 17, 2021 23:49
v. 2
Aug 17, 2021 23:46
v. 1
Aug 17, 2021 23:33
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