510(k) K853848
- Device
- RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
- Applicant
- MEDICAL GRAPHICS CORP.
- 510(k) number
- K853848
- Product code
- BXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-05
- Date received
- 1985-09-16
- Regulation
- 868.1870
- Classification name
- Calibrator, Volume, Gas
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD BERGESON
- Address
- 501 W. County Rd. E St. Paul MN US 55112 55112
FDA Registration Numbers#
- 9710567
- 3010381606
- 3020614
- 3012302888
- 3002808458
- 3010082909
- 3009443693
- 3008317830
- 3021284283
- 1922553
- 3033959233
- 1924066
- 3012309966
- 1836161
- 9615102
- 3010187802
- 3013298431
- 2133542
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831758 | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | 1983-07-19 |
| K830898 | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | 1983-05-16 |
| K812765 | DATASCRIBE #DS-40 | Timeter Instrument Corp. | 1981-11-16 |
| K810290 | OHIO CAL-CHEK | Ohio Medical Products | 1981-02-12 |
| K760520 | CALIPERS, MCGAW SKINFOLD | Mcgaw Laboratories | 1976-11-12 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases