FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXTUBE, CONNECTING TUBING
K Number: K860877
·
Decision Mar 20, 1986
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
43
Review Days
23
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Basic Information
- Device Name
- FLEXTUBE, CONNECTING TUBING
- K Number
- K860877
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
- Date Received
- February 25, 1986
- Decision Date
- March 20, 1986
- Product Code
- BYX
- 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
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Other Clearances by Dhd Medical Products Div. Diemolding Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883988 | NON-REBREATHING TEE PIECE (NRTP) | Oct 7, 1988 | Substantially Equivalent |
| K881935 | MICROCIRRUS MEDICAL NEBULIZER | Jun 22, 1988 | Substantially Equivalent |
| K881178 | CUFFCHECK | Apr 14, 1988 | Substantially Equivalent |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Mar 9, 1988 | Substantially Equivalent |
| K874047 | ASTHMAKIT | Feb 29, 1988 | Substantially Equivalent |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | Oct 30, 1987 | Substantially Equivalent |
| K860873 | VENTURI MASK/ADULT & PAEDIATRIC | Mar 20, 1986 | Substantially Equivalent |
| K860879 | DISPOSABLE VENTILATOR CIRCUITS | Mar 20, 1986 | Substantially Equivalent |
| K860880 | VENTILATOR CIRCUITS (VARIOUS TYPES) | Mar 20, 1986 | Substantially Equivalent |
| K860878 | BRITISH BREATHING CIRCUIT SYSTEM | Mar 20, 1986 | Substantially Equivalent |