510(k) K974228
K974228 is an FDA 510(k) premarket notification submitted by Gps for the device "HOSPITAL'S SPEC". The FDA issued a decision of Substantially Equivalent on December 12, 1997. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Gps has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1997
- Date Received
- November 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type