Submission Details
| 510(k) Number | K902060 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 1990 |
| Decision Date | June 11, 1990 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
K902060 - ESCORT MODEL 300
(FDA 510(k) Clearance)
Jun 1990
Decision
35d
Days
Class 2
Risk
K902060 is an FDA 510(k) clearance for the ESCORT MODEL 300. This device is classified as a Oximeter (Class II — Special Controls, product code DQA).
Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on June 11, 1990, 35 days after receiving the submission on May 7, 1990.
This device falls under the Anesthesiology FDA 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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