510(k) K761341
- Device
- PORTAGAS AERATOR
- Applicant
- Amsco Co.
- 510(k) number
- K761341
- Product code
- FLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-28
- Date received
- 1976-12-28
- Regulation
- 880.6100
- Classification name
- Cabinet, Ethylene-Oxide Gas Aerator
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3042272797
- 3031841433
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904921 | STERI-VAC(TM) AERATOR MODEL XL | 3M Health Care, Ltd. | 1990-12-05 |
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Gas-Vak | 1990-10-15 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | 1983-06-15 |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | 1983-04-12 |
| K813201 | CASTLE #3241 GAS AERATOR | Sybron Corp. | 1981-12-31 |
| K790677 | EO EVACUATING SYSTEM I | Castle Co. | 1979-05-07 |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | 1978-10-27 |