K894170 is an FDA 510(k) clearance for the DEVON DISPOSABLE HEAD POSITIONER COVER. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on September 7, 1989, 84 days after receiving the submission on June 15, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K894170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1989 |
| Decision Date | September 07, 1989 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |