Modification To:Accu-Chek Pocket Compass Diabetes Management Software
FDA 510(k) K082595 · Roche Diagnostics
510(k) numberK082595
Submission
- Device name
- Modification To:Accu-Chek Pocket Compass Diabetes Management Software
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- September 8, 2008
- Decision date
- October 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Modification To:Accu-Chek Pocket Compass Diabetes Management Software cleared by the FDA?
Modification To:Accu-Chek Pocket Compass Diabetes Management Software (K082595) received a 510(k) decision of Substantially Equivalent on October 28, 2008, 50 days after the submission was received.
What is the product code of K082595?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.