FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
K Number: K895853
·
Decision Dec 22, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
23
Review Days
80
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
- SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
- K Number
- K895853
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sechrist Industries, Inc.
- Date Received
- October 3, 1989
- Decision Date
- December 22, 1989
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Sechrist Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | May 30, 2014 | Substantially Equivalent |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Apr 26, 2010 | Substantially Equivalent |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Oct 28, 2005 | Substantially Equivalent |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Jan 17, 2003 | Substantially Equivalent |
| K993167 | MILLENNIUM INFANT VENTILATOR | Nov 10, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | Aug 10, 1999 | Substantially Equivalent |
| K934164 | MODEL 2500E/2500ER HYPERBARIC CHAMBER | Jun 13, 1995 | Substantially Equivalent |
| K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER | Jun 13, 1995 | Substantially Equivalent |
| K930713 | THE INFANT FLOW SYSTEM | Sep 16, 1993 | Substantially Equivalent |
| K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B | Nov 2, 1992 | Substantially Equivalent |