K884823 is an FDA 510(k) clearance for the TRANSPAC(R) II, DISPOSABLE TRANSDUCER. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 3, 1990, 592 days after receiving the submission on November 18, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K884823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1988 |
| Decision Date | July 03, 1990 |
| Days to Decision | 592 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWM — Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |