510(k) K842128
K842128 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMERICAN MEDICAL OPTICS PHOTOKERATO". The FDA issued a decision of Substantially Equivalent on Aug 7, 1984. The device falls under product code HJA (Photokeratoscope), a Class I device regulated under 21 CFR 886.1350. American Medical Optics has 16 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 7, 1984
- Date Received
- May 29, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Photokeratoscope
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt