510(k) K904992
- Device
- MINNILERT AIR DETECTOR
- Applicant
- MINNTECH CORP.
- 510(k) number
- K904992
- Product code
- FJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-05
- Date received
- 1990-11-07
- Regulation
- 876.5820
- Classification name
- Detector, Air Bubble
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEROY J FISCHBACH
- Address
- 14605 28th Ave. N. Minneapolis MN US 55447 55447
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891327 | NICKLE-TITANIUM ORTHODONTIC WIRE | American Orthodontics | 1989-05-10 |
| K781330 | BLOOD LEVEL DETECTOR-MODEL 7601 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| K780582 | DETECTOR, BUBBLE & FOAM | Hospal Medical Corp. | 1978-06-22 |
| K770857 | DIALYSIS MACHINE, CENTRY II | Cobe Laboratories, Inc. | 1977-10-04 |
Legacy Summary#
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FDA Review#
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