External Pacemaker Analyzer, Model PMT 100
FDA 510(k) K961582 · North American Technical Services Corp.
510(k) numberK961582
Submission
- Device name
- External Pacemaker Analyzer, Model PMT 100
- Applicant
- North American Technical Services Corp.
Sound Beach, NY, US - Received
- April 24, 1996
- Decision date
- November 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
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| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
| K884331 | Medtronic Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 01/10/1989SE |
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Questions and answers
When was External Pacemaker Analyzer, Model PMT 100 cleared by the FDA?
External Pacemaker Analyzer, Model PMT 100 (K961582) received a 510(k) decision of Substantially Equivalent on November 8, 1996, 198 days after the submission was received.
What is the product code of K961582?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.