510(k) K032593
- Device
- MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
- Applicant
- MERCURY MEDICAL
- 510(k) number
- K032593
- Product code
- BXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-03
- Date received
- 2003-08-22
- Regulation
- 868.1780
- Classification name
- Meter, Airway Pressure (inspiratory Force)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE GLOVER
- Address
- 11300 49th St. N. Clearwater FL US 33762 33762
FDA Registration Numbers#
- 1526863
- 3012307300
- 2518436
- 8044169
- 1024404
Source Documents#
Other 510(k) Records For Product Code BXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Instrumentation Industries, Inc. | 2008-09-11 |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Warren E. Collins, Inc. | 1992-01-15 |
| K904917 | THAYER MIP ADAPTER | Thayer Medical Corp. | 1991-01-28 |
| K901998 | DIGITAL MANOMETER (DM 50) | Medical Support Products, Inc. | 1990-07-25 |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 |
Legacy Summary#
summary
FDA Review#
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