Space Labs Model 90560
FDA 510(k) K923788 · Spacelabs, Inc.
510(k) numberK923788
Submission
- Device name
- Space Labs Model 90560
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- July 28, 1992
- Decision date
- December 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
| K904318 | Local Report GeneratorDXN · Traditional | 12/18/1990SE |
Questions and answers
When was Space Labs Model 90560 cleared by the FDA?
Space Labs Model 90560 (K923788) received a 510(k) decision of Substantially Equivalent on December 6, 1993, 496 days after the submission was received.