510(k) K993826
- Device
- NARKOMED 6000
- Applicant
- DRAEGER MEDICAL, INC.
- 510(k) number
- K993826
- Product code
- MLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-23
- Date received
- 1999-11-12
- Regulation
- 870.2340
- Classification name
- Monitor, St Segment
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GALE E WINARSKY
- Address
- 3135 Quarry Rd. Telford PA US 18969 18969
FDA Registration Numbers#
- 3007603826
- 3013500228
- 3000126629
- 3012528160
- 3009156722
- 3013596024
- 3033959233
- 9610816
- 2221819
- 9615102
- 3009077524
- 3003263092
- 3016701404
Source Documents#
Other 510(k) Records For Product Code MLC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926099 | DATASCOPE 6000 MONITOR | Datascope Corp. | 1993-08-06 |
Legacy Summary#
summary
FDA Review#
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