K880903 is an FDA 510(k) clearance for the BARD (R) ESKA ERECTIOMETER. This device is classified as a Monitor, Penile Tumescence.
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 6, 1988, 65 days after receiving the submission on March 2, 1988.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K880903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1988 |
| Decision Date | May 06, 1988 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LIL — Monitor, Penile Tumescence |
| Device Class | — |