FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOUTHPIECE M-187
K Number: K790933
·
Decision May 21, 1979
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
27
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
- MOUTHPIECE M-187
- K Number
- K790933
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mem Medical, Inc.
- Date Received
- May 15, 1979
- Decision Date
- May 21, 1979
- Product Code
- BYP
- 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYP), ordered by most recent decision date.
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
TRUZONE PFM DISPOSABLE MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
BREATHING MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
AEROCHAMBER
FDA 510(k)
FDA Class 1
·Anesthesiology
SAFE-T-SHIELD MOUTHPIECE
FDA 510(k)
FDA Class 1
·Anesthesiology
INHALATION AID
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Mem Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791911 | FALL-SAFE IMV #M-511 | Oct 9, 1979 | Substantially Equivalent |
| K791913 | IMV MANIFOLD #M-506 | Oct 9, 1979 | Substantially Equivalent |
| K791906 | IMV W/BAG #M-507 | Oct 9, 1979 | Substantially Equivalent |
| K791907 | RETARD VALVE 3-STACK #M-515 | Oct 9, 1979 | Substantially Equivalent |
| K791904 | IMV W/BAG & HOSES #M-509 | Oct 9, 1979 | Substantially Equivalent |
| K791908 | RETARD VALVE 3-STACK #M-514 | Oct 9, 1979 | Substantially Equivalent |
| K791909 | IMV BUSHING #M-513 | Oct 9, 1979 | Substantially Equivalent |
| K791910 | THREE LITER BAG #M-512 | Oct 9, 1979 | Substantially Equivalent |
| K791905 | IMV W/BAG & TUBING #M-508 | Oct 9, 1979 | Substantially Equivalent |
| K791912 | IMV FOR MONITORING #M-510 | Oct 9, 1979 | Substantially Equivalent |