FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SALINE SOLUTION- STERILE
K Number: K922033
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
44
Review Days
81
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
- SALINE SOLUTION- STERILE
- K Number
- K922033
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trinity Laboratories, Inc.
- Date Received
- May 1, 1992
- Decision Date
- July 21, 1992
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCQ), ordered by most recent decision date.
EZ SPRAY
FDA 510(k)
FDA Class 1
·Anesthesiology
E-Z SPACER MASK (SMALL)
FDA 510(k)
FDA Class 1
·Anesthesiology
MDI TUTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
MEDSHIELD/AEROCHAMBER
FDA 510(k)
FDA Class 1
·Anesthesiology
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
FDA 510(k)
FDA Class 1
·Anesthesiology
MODIFIED AEROCHAMBER WITH MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Trinity Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | Jul 10, 1998 | Substantially Equivalent |
| K974238 | DENTAL TRAY, STERILE, DISPOSABLE | Feb 4, 1998 | Substantially Equivalent |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Dec 12, 1997 | Substantially Equivalent |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | Aug 1, 1997 | Substantially Equivalent |
| K970722 | EYE TRAY | Mar 31, 1997 | Substantially Equivalent |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Feb 14, 1997 | Unknown |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Jan 22, 1997 | Substantially Equivalent |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Nov 16, 1995 | Substantially Equivalent |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | Sep 21, 1995 | Substantially Equivalent |
| K953070 | WOUNDFOAM 4 X 4 | Sep 8, 1995 | Substantially Equivalent |