K973128 is an FDA 510(k) clearance for the OLYMPUS NA-10J-1 ASPIRATION NEEDLE. This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).
Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on November 18, 1997, 89 days after receiving the submission on August 21, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K973128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1997 |
| Decision Date | November 18, 1997 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | FOG — Hood, Oxygen, Infant |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5700 |