Spacelab Model 90845 PCMS Multidisclosure Station
FDA 510(k) K913038 · Spacelabs, Inc.
510(k) numberK913038
Submission
- Device name
- Spacelab Model 90845 PCMS Multidisclosure Station
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- July 9, 1991
- Decision date
- October 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| 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 Spacelab Model 90845 PCMS Multidisclosure Station cleared by the FDA?
Spacelab Model 90845 PCMS Multidisclosure Station (K913038) received a 510(k) decision of Substantially Equivalent on October 4, 1991, 87 days after the submission was received.
What is the product code of K913038?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.