510(k) K801563
K801563 is an FDA 510(k) premarket notification submitted by Dr. Bruno Lange GmbH for the device "PHOTOMETER LP 3". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Dr. Bruno Lange GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1980
- Date Received
- July 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2300
- Review Panel
- CH
- Submission Type