Version Published Changed By Comment Actions
CURRENT (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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