Submission Details
| 510(k) Number | K050753 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 23, 2005 |
| Decision Date | May 18, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STRYKER DISCMONITOR
May 2005
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K050753 is an FDA 510(k) clearance for the STRYKER DISCMONITOR, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 18, 2005, 56 days after receiving the submission on March 23, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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