510(k) K884685
K884685 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ROCKET FETAL BLOOD SAMPLING TRAY". The FDA issued a decision of Substantially Equivalent on January 12, 1989. The device falls under product code HGW (Sampler, Blood, Fetal), a Class II device regulated under 21 CFR 884.1560. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1989
- Date Received
- November 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sampler, Blood, Fetal
- Device Class
- Class II
- Regulation Number
- 884.1560
- Review Panel
- OB
- Submission Type