FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGYLE TRU-VOL
K Number: K800386
·
Decision Feb 28, 1980
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
191
Review Days
6
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
- ARGYLE TRU-VOL
- K Number
- K800386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- February 22, 1980
- Decision Date
- February 28, 1980
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWF), ordered by most recent decision date.
InSee
FDA 510(k)
FDA Class 2
·Anesthesiology
AllPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
LungTrainer (MD2 & MD3)
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathe+
FDA 510(k)
FDA Class 2
·Anesthesiology
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulsehaler
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Sherwood Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Nov 25, 1998 | Substantially Equivalent |
| K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | Dec 23, 1996 | Substantially Equivalent |
| K962880 | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM | Dec 9, 1996 | Unknown |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |