COLLINS DIGITAL PULMONARY MANOMETER
FDA 510(k) clearance K912946 · decided 1992-01-15
Clearance details
- K-number
- K912946
- Device name
- COLLINS DIGITAL PULMONARY MANOMETER
- Applicant
- Warren E. Collins, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-05
- Decision date
- 1992-01-15
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- BXR
- Device class
- 2
- Regulation number
- 868.1780
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Braintree, MA, 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 |
| MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (K032593) | Mercury Medical | 2004-02-03 |
| 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.