Pantridge MK III Defibrillator/Monitor
FDA 510(k) K780416 · Ipco Corp.
510(k) numberK780416
Submission
- Device name
- Pantridge MK III Defibrillator/Monitor
- Applicant
- Ipco Corp.
Mchenry, IL, US - Received
- March 14, 1978
- Decision date
- April 21, 1978
- 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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Questions and answers
When was Pantridge MK III Defibrillator/Monitor cleared by the FDA?
Pantridge MK III Defibrillator/Monitor (K780416) received a 510(k) decision of Substantially Equivalent on April 21, 1978, 38 days after the submission was received.
What is the product code of K780416?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.