Zoll M Series SPO2 Option
FDA 510(k) K982992 · Zoll Medical Corp
Submission
- Device name
- Zoll M Series SPO2 Option
- Applicant
- Zoll Medical Corp
Burlington, MA, US - Received
- August 27, 1998
- Decision date
- March 11, 1999
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
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Questions and answers
When was Zoll M Series SPO2 Option cleared by the FDA?
Zoll M Series SPO2 Option (K982992) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on March 11, 1999, 196 days after the submission was received.
What is the product code of K982992?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.