510(k) K830898
- Device
- SYRINGE 500BC BE #7000
- Applicant
- INSTRUMENTATION INDUSTRIES, INC.
- 510(k) number
- K830898
- Product code
- BXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-16
- Date received
- 1983-03-21
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010381606
- 3033959233
- 3010187802
- 1836161
- 3008317830
- 1922553
- 2133542
- 1924066
- 3012302888
- 3012309966
- 3020614
- 9615102
- 3002808458
- 3009443693
- 9710567
- 3013298431
- 3010082909
- 3021284283
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | 1985-12-05 |
| K831758 | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | 1983-07-19 |
| 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#
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FDA Review#
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