FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRRIGATION BOTTLE
K Number: K973829
·
Decision Feb 23, 1998
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
21
Review Days
139
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
- IRRIGATION BOTTLE
- K Number
- K973829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Automatic Liquid Packaging, Inc.
- Date Received
- October 7, 1997
- Decision Date
- February 23, 1998
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOH), ordered by most recent decision date.
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
FDA 510(k)
FDA Class 2
·Anesthesiology
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
TRACOE vario
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
FDA 510(k)
FDA Class 2
·Anesthesiology
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Neonatal/Pediatric Tracheostomy Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Automatic Liquid Packaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Oct 25, 2000 | Substantially Equivalent |
| K000964 | STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 | Apr 25, 2000 | Substantially Equivalent |
| K980147 | YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION | Apr 13, 1998 | Substantially Equivalent |
| K962079 | HUMIDIFIER ADAPTER | Jul 31, 1996 | Substantially Equivalent |
| K955104 | HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER | Jun 11, 1996 | Substantially Equivalent |
| K920306 | OPTI-MOL FILTERED PUNCTURE PIN | Apr 6, 1992 | Substantially Equivalent |
| K911770 | OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM | Oct 15, 1991 | Substantially Equivalent |
| K901762 | PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM | Jul 17, 1990 | Substantially Equivalent |
| K901362 | ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE | Jun 6, 1990 | Substantially Equivalent |
| K901301 | STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL | May 31, 1990 | Substantially Equivalent |