FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K Number: K873286
·
Decision Oct 26, 1987
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
27
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
- K Number
- K873286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hospitak, Inc.
- Date Received
- August 17, 1987
- Decision Date
- October 26, 1987
- Product Code
- BTM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTM), ordered by most recent decision date.
The BAG manual resuscitator and accessories
FDA 510(k)
FDA Class 2
·Anesthesiology
butterflyBVM
FDA 510(k)
FDA Class 2
·Anesthesiology
EOlife®
FDA 510(k)
FDA Class 2
·Anesthesiology
Sotair Device
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Manual Resuscitator
FDA 510(k)
FDA Class 2
·Anesthesiology
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Hospitak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Feb 28, 1996 | Substantially Equivalent |
| K954787 | ILLUMINATOR | Jan 31, 1996 | Substantially Equivalent |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K953619 | WARM N WET HME W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | Nov 30, 1994 | Substantially Equivalent |
| K920842 | AEROSOL DELIVERY SYSTEMS | May 15, 1992 | Substantially Equivalent |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent |
| K853600 | INFLATABLE AIR SPLINTS | Sep 19, 1985 | Substantially Equivalent |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent |