510(k) K943259
- Device
- 1085 ULTIMATE E PLETHYSMOGRAPH
- Applicant
- MEDICAL GRAPHICS CORP.
- 510(k) number
- K943259
- Product code
- CCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-10
- Date received
- 1994-07-06
- Regulation
- 868.2300
- Classification name
- Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHRYN A NEUMANN
- Address
- 350 Oak Grove Pkwy. St. Paul MN US 55127 55127
FDA Registration Numbers#
- 2183022
- 9615102
Source Documents#
Other 510(k) Records For Product Code CCN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934945 | FLOWMETER NIPPLE ADAPTOR | Cardio-Search , Ltd. | 1993-11-17 |
| K920783 | OXYGEN FLOW CONTROLLER | Puritan Bennett Corp. | 1992-09-18 |
| K872038 | NEB-U-VENT | Design Technologies, Inc. | 1987-08-10 |
| K871262 | MODIFIED NOFLO I | Design Technologies, Inc. | 1987-07-21 |
| K863613 | NO-FLO I | Design Technologies, Inc. | 1986-12-15 |
| K863657 | OXYGEN CONSERVATOR | Salter Labs | 1986-10-15 |
| K863659 | FLOW INTERRUPTION INDICATOR | Salter Labs | 1986-10-15 |
| K823775 | BORDON GAGE REGULATOR #BG | Timeter Instrument Corp. | 1983-01-14 |
| K802037 | VITAMIN B12 FOLATE RADIOASSAY | Corning Medical & Scientific | 1980-11-21 |
Legacy Summary#
summary
FDA Review#
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