Anesthesiometer
FDA 510(k) K851557 · Luneau SA
510(k) numberK851557
Submission
- Device name
- Anesthesiometer
- Applicant
- Luneau SA
Chartres Cedex, FR - Received
- April 16, 1985
- Decision date
- May 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HJC – Esthesiometer, Ocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1040
- Specialty
- Ophthalmic
Other 510(k)s with product code HJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920271 | Weinstein Corneal MircoaesthesiometerHJC · Traditional | Connecticut Bioinstruments, Inc. | 04/21/1992SE |
More from Connecticut Bioinstruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | 06/01/2015SE |
| K023838 | Luneau Sterile Tonometer Separation PrismsHKY · Traditional | 02/20/2003SE |
| K022413 | Luneau 3 Mirror LensHJK · Traditional | 09/24/2002SE |
Questions and answers
When was Anesthesiometer cleared by the FDA?
Anesthesiometer (K851557) received a 510(k) decision of Substantially Equivalent on May 30, 1985, 44 days after the submission was received.
What is the product code of K851557?
The FDA product code is HJC – Esthesiometer, Ocular, a Class I (low risk) device regulated under 21 CFR 886.1040.