510(k) K912444
- Device
- MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
- Applicant
- RADIOMETER AMERICA, INC.
- 510(k) number
- K912444
- Product code
- LGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-18
- Date received
- 1991-06-03
- Regulation
- 880.5450
- Classification name
- Chamber, Patient Isolation
- Medical specialty
- General Hospital
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHLEEN M ONTKO
- Address
- 811 Sharon Dr. Westlake OH US 44145 44145
FDA Registration Numbers#
- 3006076009
- 3023194188
- 9616096
- 3014421917
- 3010844918
- 3038166862
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | 2024-01-03 |
| K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | 2017-11-02 |
| K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 | Gentex Corporation | 2009-01-30 |
| K022260 | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | Isolation Systems, Inc. | 2002-08-29 |
| K944133 | MTB 1043 TREATMENT BOOTH | Mark Solutions, Inc. | 1995-09-07 |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | J. H. Emerson Co. | 1990-01-22 |
| K884295 | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE | Saybrex Intl., Inc. | 1988-11-08 |
| K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | Busse Hospital Disposables, Inc. | 1988-03-22 |
| K864116 | ANAGO ISOLATION MASK (#80-950) | Anago, Inc. | 1986-11-25 |
| K831062 | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | 1983-04-13 |
| K790657 | STRETCHER TRANSIT ISOLATER #122 | Vickers America Medical Corp. | 1979-07-03 |
Legacy Summary#
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FDA Review#
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