Pacer Sensing Analyzer (Psa 100)
FDA 510(k) K882327 · Oscor Medical Corp.
510(k) numberK882327
Submission
- Device name
- Pacer Sensing Analyzer (Psa 100)
- Applicant
- Oscor Medical Corp.
Palm Harbor, FL, US - Received
- June 6, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| 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 |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K964107 | Oscor Permanent Retractable Screw-In Pacing Lead Model PRDTB · Traditional | 04/01/1997PT |
| K925168 | Miscellaneous Pacing LeadDTD · Traditional | 05/03/1994SE |
| K923621 | External Demand PacemakerDTE · Traditional | 05/19/1993SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | 01/27/1992SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | 09/23/1991SE |
Questions and answers
When was Pacer Sensing Analyzer (Psa 100) cleared by the FDA?
Pacer Sensing Analyzer (Psa 100) (K882327) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 122 days after the submission was received.
What is the product code of K882327?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.