Defibrillator Lead Adapter
FDA 510(k) K905065 · Spacelabs, Inc.
510(k) numberK905065
Submission
- Device name
- Defibrillator Lead Adapter
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- November 7, 1990
- Decision date
- April 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
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Questions and answers
When was Defibrillator Lead Adapter cleared by the FDA?
Defibrillator Lead Adapter (K905065) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 156 days after the submission was received.
What is the product code of K905065?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.