510(k) K884684
K884684 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ROCKET INTRAUTERINE DEPTH SOUND". The FDA issued a decision of Substantially Equivalent on Dec 20, 1988. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. A & A Medical, Inc. has 22 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 1988
- Date Received
- Nov 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sound, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k) Exempt