K952328 is an FDA 510(k) clearance for the NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01. This device is classified as a Implantable Pacemaker Pulse-generator (Class III - Premarket Approval, product code DXY).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 29, 1995, 134 days after receiving the submission on May 18, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K952328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | May 18, 1995 |
| Decision Date | September 29, 1995 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |