MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
FDA 510(k) clearance K032593 · decided 2004-02-03
Clearance details
- K-number
- K032593
- Device name
- MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
- Applicant
- Mercury Medical
- Decision
- Substantially Equivalent
- Date received
- 2003-08-22
- Decision date
- 2004-02-03
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- BXR
- Device class
- 2
- Regulation number
- 868.1780
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (K081693) | Instrumentation Industries, Inc. | 2008-09-11 |
| COLLINS DIGITAL PULMONARY MANOMETER (K912946) | Warren E. Collins, Inc. | 1992-01-15 |
| THAYER MIP ADAPTER (K904917) | Thayer Medical Corp. | 1991-01-28 |
| DIGITAL MANOMETER (DM 50) (K901998) | Medical Support Products, Inc. | 1990-07-25 |
| INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (K873498) | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 |
Recalls involving this device
No recalls on record reference this clearance.