Submission Details
| 510(k) Number | K014294 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2001 |
| Decision Date | January 25, 2002 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
Jan 2002
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K014294 is an FDA 510(k) clearance for the MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414, a Oximeter (Class II — Special Controls, product code DQA), submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on January 25, 2002, 28 days after receiving the submission on December 28, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.
Device Classification
| Product Code | DQA — Oximeter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
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