510(k) K771900
K771900 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "71110 DESK CHARGER". The FDA issued a decision of Substantially Equivalent on November 9, 1977. The device falls under product code HLS (Exophthalmometer), a Class I device regulated under 21 CFR 886.1270. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1977
- Date Received
- October 6, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exophthalmometer
- Device Class
- Class I
- Regulation Number
- 886.1270
- Review Panel
- OP
- Submission Type