Narkomed 6000
FDA 510(k) K993826 · Draeger Medical, Inc.
510(k) numberK993826
Submission
- Device name
- Narkomed 6000
- Applicant
- Draeger Medical, Inc.
Telford, PA, US - Received
- November 12, 1999
- Decision date
- March 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLC – Monitor, St Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code MLC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926099 | Datascope 6000 MonitorMLC · Traditional | Datascope Corp. | 08/06/1993SE |
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Questions and answers
When was Narkomed 6000 cleared by the FDA?
Narkomed 6000 (K993826) received a 510(k) decision of Substantially Equivalent on March 23, 2000, 132 days after the submission was received.
What is the product code of K993826?
The FDA product code is MLC – Monitor, St Segment, a Class II (moderate risk) device regulated under 21 CFR 870.2340.