510(k) K910982
- Device
- INNERVISION IRRIGATION PUMP
- Applicant
- M.D. Engineering, Inc.
- 510(k) number
- K910982
- Product code
- HEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-26
- Date received
- 1991-03-07
- Regulation
- 884.2660
- Classification name
- Monitor, Heart-Valve Movement, Fetal, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW HALSEY
- Address
- 2536 Barrington Ct. Hayward CA US 94545 94545
Source Documents#
510(k) summary PDF not indicated by FDA