510(k) K950377
K950377 is an FDA 510(k) premarket notification submitted by Parker Treadmill Co., Inc. for the device "PARKER MODEL PE". The FDA issued a decision of Substantially Equivalent on September 6, 1995. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Parker Treadmill Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1995
- Date Received
- January 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Treadmill, Powered
- Device Class
- Class I
- Regulation Number
- 890.5380
- Review Panel
- PM
- Submission Type