510(k) K901998
- Device
- DIGITAL MANOMETER (DM 50)
- Applicant
- MEDICAL SUPPORT PRODUCTS, INC.
- 510(k) number
- K901998
- Product code
- BXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-25
- Date received
- 1990-05-02
- Regulation
- 868.1780
- Classification name
- Meter, Airway Pressure (inspiratory Force)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NELSON SHERTZER
- Address
- 3401 Charlestown Rd. Lancaster PA US 17603 17603
FDA Registration Numbers#
- 2518436
- 1024404
- 1526863
- 8044169
- 3012307300
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Mercury Medical | 2004-02-03 |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Warren E. Collins, Inc. | 1992-01-15 |
| K904917 | THAYER MIP ADAPTER | Thayer Medical Corp. | 1991-01-28 |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 |
Legacy Summary#
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FDA Review#
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