510(k) K870039
K870039 is an FDA 510(k) premarket notification submitted by Par Microsystems Corp. for the device "IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Par Microsystems Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1987
- Date Received
- January 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Paper Chart
- Device Class
- Class I
- Regulation Number
- 870.2810
- Review Panel
- CV
- Submission Type