Respiratory Diagnostic Equipment Calibrator
FDA 510(k) K853848 · Medical Graphics Corp.
510(k) numberK853848
Submission
- Device name
- Respiratory Diagnostic Equipment Calibrator
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- September 16, 1985
- Decision date
- December 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXW – Calibrator, Volume, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1870
- Specialty
- Anesthesiology
Other 510(k)s with product code BXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831758 | Flow-Calibration ModuleBXW · Traditional | The Perkin-Elmer Corp. | 07/19/1983SE |
| K830898 | Syringe 500BC Be #7000BXW · Traditional | Instrumentation Industries, Inc. | 05/16/1983SE |
| K812765 | Datascribe #DS-40BXW · Traditional | Timeter Instrument Corp. | 11/16/1981SE |
| K810290 | Ohio Cal-ChekBXW · Traditional | Ohio Medical Products | 02/12/1981SE |
| K760520 | Calipers, Mcgaw SkinfoldBXW · Traditional | Mcgaw Laboratories | 11/12/1976SE |
More from Mcgaw Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 10/17/2024SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 04/12/2019SE |
| K152585 | Resmon PRO FULLPNV · Traditional | 06/24/2016SE |
| K070858 | Express SeriesBZL · Special | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | 09/06/2006SE |
| K955432 | CPX, CCM, Cath with 15% CO2BZM · Traditional | 07/01/1996SE |
| K943259 | 1085 Ultimate E PlethysmographCCM · Traditional | 04/10/1995SE |
| K923209 | Medgraphics Exercise ConsultBZM · Traditional | 03/11/1993SE |
| K912906 | Medgraphics Pf/DxBZL · Traditional | 02/04/1992SE |
| K896345 | Exercise Evaluation System 2010BZM · Traditional | 01/20/1990SE |
Questions and answers
When was Respiratory Diagnostic Equipment Calibrator cleared by the FDA?
Respiratory Diagnostic Equipment Calibrator (K853848) received a 510(k) decision of Substantially Equivalent on December 5, 1985, 80 days after the submission was received.
What is the product code of K853848?
The FDA product code is BXW – Calibrator, Volume, Gas, a Class I (low risk) device regulated under 21 CFR 868.1870.